Misplaced Pages

Revision as of 01:57, 11 November 2006

Please stay calm and civil while commenting or presenting evidence, and do not make personal attacks. Be patient when approaching solutions to any issues. If consensus is not reached, other solutions exist to draw attention and ensure that more editors mediate or comment on the dispute.

"are not to be confused"

i think that wording is pov--tells people what to think; doesn't present info. the drugs in ecp have differences from and similarites to drugs used in chemical abortion (when they are the same drugs, and when they are similar drugs). whether or not the mechanism of action is the same is not the only issue viz the drugs--there are other issues such as side effects, etc. should probably also be added that ecp has differences from and similarities to bc pills/pop-only contraception, since levo is same progestin. (i.e., side effects from levo in ecp are same as side effects from levo pocp, with differences in effect applying to duration of use/how strong the dose.) Cindery 18:19, 29 August 2006 (UTC)

... in addition, the difference between levonorgestrel and mifepristone really needs to be made clear. if you read gemzell carefully, levo has no abortifacient potential, but mifepristone does (by necrotizing decidual tissue). and the dose available for mifepristone as ec--200mg--is the same dose widely used for chemical abortion based on the "evidence-based" protocols conducted by the WHO and practiced at planned parenthood, etc: you could say "levonorgestrel should not be confused with mifepristone," but it's not at all accurate to say that mifepristone should not be confused with mifepristone...

also: neither levo nor mifepristone is a "hormone"--they are both drugs. (we could say levonorgestrel is a hormonal drug. but mifepristone is an antihormonal drug...) Cindery 17:32, 14 September 2006 (UTC)

Mifepristone has a different effect when taken before ovulation vs. after implantation, regardless of 10mg dose vs. 200mg dose. There is widespread public confusion in the U.S. between chemical abortion (drugs taken with the intention of ending an already-implanted pregnancy) and emergency contraceptive pills (drugs taken with the intention of preventing pregnancy). I like that the article tries to resolve this common confusion. Lyrl _Contribs 21:12, 14 September 2006 (UTC)

"Mifepristone blocks the effects of natural progesterone on the endometrium and decidua. This leads to degeneration and shedding of the endometrial lining, thereby preventing or disrupting implantation of the conceptus." the mechanism of action for mifepristone in ec and chemical abortion is exactly the same--it has a necrotizing effect on endometrial tissue. i think you should reread the gemzell more closely for the diff between mifepristone and levo. i realize that "intent" matters--one can't be sure that one has ovulated before or after taking mifepristone as ec, and if one intends to prevent conception rather than to abort, intent matters. i also realize that there's a big "implantation" controversy. but, the facts are the facts--intent doesn't change the drug's mechanism of action (or the possibility of aborting with mife rather than preventing conception). i think it's especially important to distingush levo from mife (because levo can't accidentally end a pregnancy someone merely wanted to prevent but wouldn't abort--the distinction supports your argument--for levo). Cindery 22:32, 14 September 2006 (UTC)

...maybe the simplest way to illustrate the difference is that, if someone miscalculated or didn't know when they ovulated (all the studies focus only on the unlikely incidence of every use of ec occurring exactly before or after ovulation--which brings up another issue--needless use of high dose hormones in the event that the ovulatory window isn't in effect, and what cumulative/repeated high doses could do) and they already happened to be pregnant, levo would have no effect on the pregnancy. but 200mg of mifepristone would be approx. %80 effective at inducing abortion all by itself at that dose. Cindery 23:31, 14 September 2006 (UTC)

Infobox effectiveness

Where did that 11% number come from? When it was in the text, it referenced this article (requires free registration) - but I can only read the abstract, and it does not say anything about an 11% effectiveness rate. I have a vague memory of reading somewhere that ECPs had an 11% failure rate if taken within 24 hours of unprotected intercourse - is that where the number came from?

In any case, should that 11% number stay in the infobox? Or should we put 25% - the failure rate when used according to package directions, which allow use up to three days after unprotected intercourse? Lyrl _Contribs 21:14, 19 September 2006 (UTC)

mifepristone as ECP reference

The study referenced supports not only the statement that the low dosage is as effective with less side effects than the high dosage, and that the low dosage works by preventing implantation, it also mentions that mifepristone can make make the uterus hostile to implantation, so the study support 3 of the sentences in that paragraph. I don't know if that effects where we place the citation or not, but I noticed the citation was moved.--Andrew c 16:24, 23 September 2006 (UTC)

this is verbatim from the wertheimer/AFP ref: "Mifepristone inhibits ovulation and blocks implantation by causing a delay in maturation of the endometrium.3 It causes actual regression of the corpus luteum in 50 percent of women when given in the middle or late luteal phase...

Only mifepristone is effective once implantation has occurred, actually interrupting an early pregnancy. The effectiveness of these methods thus depends on the point in a woman's reproductive cycle at which emergency contraception is used."

Cindery 16:33, 23 September 2006 (UTC)

mife dose efficacy

i just updated the mifepristone article with a more current ref than gemzell which states that while some studies have found no dose efficacy diff, there have not been sufficient studies to make definite claims, and that a review finds not only dose efficacy diff, but a diff between low doses, such as 10mg vs 50mg.

Piaggio G et al (2003). "Meta-analysis of randomized trials comparing different doses of mifepristone in emergency contraception". Contraception 68 (6). PMID 14698075. Cindery 16:40, 23 September 2006 (UTC)

French Polynesia?

Out of curiosity, when listing the countries who allow EBC to be handed over without prescription, why is there "France" and then "French Polynesia" listed? French Polynesia is part of France, it's not a different country even if has a special status.

Or then, out of coherence, you'd have to mention Mayotte, Wallis-et-Futuna, and Saint-Pierre-et-Miquelon who have also have special legal status as "overseas collectivities" - collectivité d'outre-mer in French.

abortion rate as a measure of EC efficacy?

One possible measure of efficacy is a lowered abortion rate. In countries where EC has been available for more than a decade, the abortion rate is not lower. The cited article only refers to Great Britain - one country, not multiple. Also, the article strongly implies that the reason the abortion rate has gone up over the past twenty years is because of lack of use of appropriate contraception, emergency or otherwise.

Abortion rates are dependent on so many factors it seems nonsensical to use them as a measure of effectiveness of a single contraception method. I support removing the quoted sentence from the article. Lyrl _Contribs 13:42, 24 September 2006 (UTC)

not a chance.

"one possible measure of efficacy" is too weak, actually--it should probably be the measure of accuracy for EC. (i notice no one objected to the listing in "misc facts and figures" that half of all US pregnancies are unintended (as an implied argument in favor of ECPs; lending the clear implication that they could lower this number). if ECPS were useful, there would be lower abortion rates in countries where they have been widely available for a long time. (but it's not surprising--the abortion rate has remained stable in france despite the contraceptive pill, as well. pills are not magic, and should never be uncritically promoted as if they are or could be.)

anna glasier (the doctor whose work is summarized in the forbes article) is the same ECP expert whose work is excerpted by permission in the wertheimer/american family physician article. (meaning: i don't think her work should be selectively presented-- depending on whether or not it is favorable to ECPs.)

and glasier specifically mentions not just the Uk, but france and sweden as well.

i think the doesn't-lower-abortion-rate should be emphasized more--there should probably be a bulleted pro-con/advantage/disadvantage section to neatly summarize/for comparison. any disadvantages of ECP are really buried in this article right now; it's not neutral at all. getting ECPs approved has been constructed as a holy war/political battle in the US, which has obscured the fact that they are for-profit pharmaceutical drugs. "like all drugs," they have advantages and disandantages. and if they only fulfill their stated purpose in theory, that's more than notable. Cindery 14:50, 24 September 2006 (UTC)

It seems inappopriate to look at abortion rates as the ultimate measure of efficacy for EC. The number of things affecting abortion rates is astronomical. When a new antibiotic is approved, we don't demand a decrease in nationwide infection rates; we just demand that the antibiotic work in an individual patient. Similarly, the measure of efficacy for EC is its effectiveness in preventing pregnancy in an individual person - which is clearly demonstrated in the literature. That is, they do "fulfill their stated purpose". It would be great if it reduced abortion rates too, but that's a social issue much bigger than EC alone. The fact that abortion rates have remained constant or risen deserves mention, but not as some kind of condemnation of the effectiveness of EC. MastCell 19:26, 20 October 2006 (UTC)

relevance?

i don't understand why this was there/what point it is supposed to make? Cindery 16:57, 24 September 2006 (UTC)

"In 1998, Washington was the first state to allow women to get emergency contraception directly from a pharmacist, without first going to a doctor. Doctors and pharmacies collaborated and set up criteria that women were required to meet in order to receive emergency contraception. There were almost 35,600 prescriptions filled from February 1998 until the trial expired in June 2001."

pregnancy rate vs. reduction in pregnancy rate

I think the effectiveness section is misstated now - it seems to be confusing the pregnancy rate (actual number of pregnancies) with the reduction in that rate caused by ECPs (the change in the number of pregnancies).

To illistrate, consider the same comparison of pregnancy rate from unprotected intercourse (25%) to effectiveness of Yuzpe regimen (57%, therefore 43% failure) - it would seems that the ECPs actually dramatically increased the number of pregnancies. Lyrl _Contribs 19:23, 25 September 2006 (UTC)

...the "change" in the number of pregnancies/reduction of rate cannot be conclusively established for ECPS--only estimated and guessed at. (because there is no way to confirm if any pregnancies were actually averted. probable pregnancies--based on "conception probabilities"--factors involving unprotected sex, date of LMP, etc are all that ECPs can address. i would be in favor of reworking the section/striking the retro-comparsion of yuzpe/levo, or making it clear that that study wasn't designed to give a general picture of ECP efficacy. i think that was a poorly designed retro-analysis, that gives a confusing picture. the study designers were responding to criticisms that ECP studies overestimate the efficacy of ECPS because the study participants are more likely to have unintended pregnancies than general populations. so they tried to configure a "control group"--yuzpe-takers. "at least %50 effective but probably higher in comparison to yuzpe-takers, if yuzpe efficacy were zero" is just weird and confusing. a hypothetical pregnancy reduction rate based on conception probabilities calculated in comparison to same hypotheticals to yuzpe isn't designed to show a general efficacy rate--it's making a point about efficacy via a control group. in the context of the section in wikipedia, it does look weird--because we already have a control group not addressed in that study--the %25 pregnancy rate with unprotected sex. only in that context, could you say %57 represents an increase in pregnancies (which it does not--it would represent a hypothetical decrease in hypothetical pregnancy reduction).

i would recommend this:

• find the %11 perfect use citation to compare against %25 (because %25 is the same as unprotected sex without ECPS) or find a citation that says unprotected sex without ECPS results in higher rate than %25
• move weirdly designed yuzpe-levo comparison down, as counterpoint to a citation i will supply about ECP efficacy is overstated via use of high-risk study participants.
• clarify that the efficiacy rate is calculated by conception probabilities--hypotheticals which can't definitively establish ECP efficacy (and that the same hypotheticals apply to takers of ECPS, when they are trying to make a decision...)
• make clear that in theory, if used correctly, and with luck at calculating hypotheticals through calendar method fertility awareness (which is the method all the studies seem to refer to for purpose of calculating conception probabilities) ECPs could prevent an unwanted pregnancy. (but no studies have established their usefulness at actually accomplishing that in practice.)

Cindery 20:48, 25 September 2006 (UTC)

To address the bulleted points above:

• I had already put a note on the talk page (#Infobox effectiveness) asking where that 11% number came from.
• The Yuzpe-levo study seems to be the closest to a controlled study of effectiveness that exists. It is the only one that does not rely on hypothetical fertility rates, but rather compares actual pregnancy rates between two groups of women seeking emergency birth control. I view it as a very important study in confirming the effectiveness of ECPs in preventing pregnancy.
• I tried to explain the uncertainties involved in calculating effectiveness of ECPs when I wrote ...determining the risk of pregnancy from a single act of intercourse is extremely difficult. For this reason, it is challenging to conduct rigorous studies to determine the effectiveness of emergency contraceptive pills. Feel free to reword to make the language more accessible.
• Studies have definitively shown that ECPs frequently prevent ovulation. Many studies have concluded that ECPs reduce pregnancy rates. I understand the uncertainties in calculating exact effectiveness rates, but I'm not grasping the reasoning of saying they do not work at all.

Also remember, that 25% pregnancies-from-unprotected-intercourse number is for multiple acts of intercourse throughout the month/menstrual cycle, and is the actual pregnancy rate (25 out of 100 women pregnant). The ECP failure rate is for a single act of intercourse. Say (for arguments sake) the chance of pregnancy from that one act of intercourse was 8%. If the woman took ECPs, and reduced her risk of pregnancy by 75%, she would have reduced her risk of pregnancy to 2%. So (in this hypothetical) a 25% failure rate would equate to a 2% pregnancy rate (2 women out of 100 pregnant). Comparing the failure rate of ECPs to the pregnancy rate for multiple acts of intercourse is not a valid comparison. Lyrl _Contribs 23:00, 25 September 2006 (UTC)

i see what you're saying--based on clinical trials in which people had a single act of intercourse--and in which the risk of pregnancy from a single act of intercourse was estimated to be %8--ECPs supposedly reduced the risk to %1-2. the problem comes in two places: 1) the %8 is outrageously faulty--the risk of getting pregnant isn't a steady %8 all month, as you point out, it fluctuates extremely 2) people don't have a single act of intercourse--they have sex all month. i think this should be explained in the article--that instead of saying "it is very difficult to calculate the efficacy, etc..." we should explain what the circumstances of "perfect use" are--a single monthly act of intercourse, during the 72 hour ovulatory window. multiple acts, miscalculation of ovulation can drastically reduce the efficacy rate; and there is an extremely high chance of spending money/taking a dangerously high dose of hormones for nothing. (in fact, the chances of taking the drugs needlessly are greater than the chance of taking them to prevent pregnancy.) Cindery 01:08, 26 September 2006 (UTC)

darney study

this is the last time i am going to make it clear that there was NO non-ecp control group for that study. everyone had access to ecps. there was no "traditonal care." the point of the study was to prove that younger adolescents don't have more risky sex than slightly older people when they all have access to ecps. the other study didn't address ecps+ risky sex at all--it merely mentioned it. the point of that study was drug safety profile in comparison to oral contraceptives. whomever the anon is who apparently hasn't read either of these studies and keeps incorrectly summarizing them--i'm just going to put an accuracy tag if you revert again. Cindery 20:57, 29 September 2006 (UTC)

Related Statistics and Studies

Hey Cindery. First of all, sorry about commenting on your personal talk page, as a newbie I thought you were referring to this when you said to refer to the "talk" page (plus I did look at the talk page and I never saw a discussion on any of our issues). Anyways, I wasn't trying to be inflamatory.

In regards to your comments, I can tell you that "control groups" are not always a group that has never received any treatment at all. For instance, if I am running an experiment where I'm injecting a drug into the brain, the control group would be a group that I inject saline into the same area (as opposed to injecting the drug). As a result, I "control" everything except for the thing I'm interested in. For instance, the actual surgery could cause problems on its own unrelated to the adminstration of drug. Therefore, I'm controlling for everything except for the drug I'm injecting. In the same way, the study I'm referencing controls for everything except for the fact that they have easy access to ECPs as opposed to people who are in a situation in which they can recieve ECPs only by prescription (the control group in this situation is a person who can only receive ECPs via prescription as opposed to a person in which ECPs are available readily). Therefore, the group receiving traditional treatment is a better control (as opposed to a contrived group having little relevance to the question in hand). Based on this information, unfortunately, your idea of a control group is completely wrong

Finally, in regard to your comment, "funded by the population council--which has a finacial stake in mifepristone", I can tell you that the publishing of a paper in which a company has a financial stake in any drug does not automatically make the study irrelevant. In fact, it is common for a drug company to publish papers in support (or against) their drug. The way the scientific community handles this issue is that any publication in a repudible journal has to fill out a "conflict of interest" form. When such a form is filled out affirming such a position, I can tell you they are scrutinized much more carefully. Hence the scientific and ethical conflicts are dealt with by anonymous ethical reviewers (almost invariably with an opposing view) who unbiasedly review the article. The simple fact that this respected journal accepted the article is evidence that the scientific process is maintained. Certainly, I believe this process is abused by non-scientists. As evidence, I refer to the article that is commonly referenced by anti-abortion web sites and, ironically, by this wikipedia page previously . The "expert", who happened to be a business professor who is an expert in the economics of cricket, wrote a very scientific looking article three years ago that has yet to get it published in a peer reviewed journal. In conclusion, all the references I've listed have maintained the highest standards in terms of the scientific principal. I would expect you to respect this process.

...WP:NOT wikipedia is not a soapbox. try to be more succinct. again, sign your posts with four tildes. for your information, i am the one who deleted the "businessman" study from the EC article, because it was not a WP:RS.

for the summary of the darney study: the study analyzed different age groups, all of whom had access to ECPs, to determine if younger people with access to ECPs would behave any differently than older people with access to ECPs. they did not. no part of the group did not have access to ECPs. therefore no assessment which implies a comparison between people who have access to ECPs and people who do not have access to ECPs is accurate. the only accurate summary reflects the point of the study: no difference between age groups who all have access to ECPs. Cindery 13:57, 30 September 2006 (UTC)

RegisA 21:34, 30 September 2006 (UTC) Hey Cindery, OK, I finally understand what you mean by four tildes. Once again, sorry I'm a newbie.

In terms of the other issues you brought up previously, I will assume you consider them settled as they were not mentioned in your reply. Therefore I wont comment on them.

In terms of the businessman article, I was the first person to realize this article was not published in a peer reviewed article and I was the one who appended this fact in the text. My problem with you removing it is that you replaced it with a summary of another article (i.e. the Swedish article) that was clearly misleading. Once again I had to append text which portrays the article fairly. Either you did not take the time to even read the abstract of the paper or you were obviously trying to spin the results unfairly. Regardless, even a newbie knows both of these things are bad etiquette on wikipedia.

This leaves the Darney study. I still don't think you actually took the time to read the study. You are correct in that they compared differences between age groups but this is one of numerous comparisons made in the article. Much of the current debate is centered on the effects of converting ECPs from prescription to over-the-counter in the United States. As a result, this is the focus of the article. Based on this information, a non-ECP control group is irrelevant as, at the very least, people in the real world (in the US prior to ECPs being available over the counter) have access to ECPs via prescription. You are focusing on a point (i.e. ECP group verses a non-ECP group) which is irrelevant. What is more relevent is a comparison between people who can only get ECPs via prescription (just like in the US before ECPs went over-the-counter) verses people who have ECPs readily available (the advance provision group). Therefore, we control for everything else except the fact that ECPs are more readily available. Established experts in the field have used this specific study to bolster the contention that making ECPs more readily available (i.e. over-the-counter) is safe (see below for text from Lancet article). Considering this exact question is debated extensively, this study is deserving of being in the ECP article.

Here is some text from the highly respected scientific journal The Lancet (The Lancet Volume 365, Issue 9472 Pages 1668-1670) Please note that in the text below the reference to the Tina Raine article is the same as the Darney study mentioned above (Raine is the first author whereas Darney is the last author on this article)

"Despite its undisputed safety and efficacy, enhancing women's access to emergency contraception has been controversial. Some of this controversy is related to the anomalous position of emergency contraception in the family-planning repertoire: anomalous because it is used after sex. At the same time, some developments in emergency contraception, aimed at combating teenage and unwanted pregnancy, have been reported in particularly lurid terms by the mass media, conflating concerns about sexual morality, inappropriate use of contraception, and the spread of sexually transmitted infections. Against this background, it is interesting to note the findings from a recent study providing evidence of the broader effects of emergency contraception on key public-health issues. Tina Raine and colleagues randomly assigned 2117 young women aged 15–24 years to either pharmacy access to emergency contraception without a prescription, advance provision of emergency contraception, or usual care (requiring a visit to a clinic). Over the 6-month follow-up, the authors report that women in the advance provision group were almost twice as likely to use emergency contraception (37•4%) than those who had pharmacy access (24•2%) or usual care (21%). Interestingly, pregnancy rates and rates of new sexually transmitted infections were similar in all the groups. Furthermore, easier access to emergency contraception did not appear to affect regular contraceptive use or risky sexual behaviours.

Like Litt, we believe this is important new evidence. Data from a recent study in Scotland reached similar conclusions. In that study, women aged 16–29 years were provided with five courses of emergency contraception to keep at home (advance supply), which they obtained when accessing general practices, family-planning clinics, or accident and emergency departments. The study concluded that advance supply was viewed positively by women and that concerns about repeated use of emergency contraception, as well as links between easier access to such contraception and risky sex or changed contraceptive behaviours, appear to be unfounded. Clearly, both studies should reassure those worried about these issues."

Clearly the conclusion of the experts in this article is that the Darney study bolsters the position that transitioning from ECPs being available through prescription to being available over-the-counter is safe.

RegisA 21:34, 30 September 2006 (UTC)

again, read WP:NOT. how many times do i need to repeat this? READ WP:NOT. do not write lonf paragraphs expressing your personal opinions. your opinion of whether or not a control group is necessary is not relevant. all that matters are the facts. the facts are that the comparison was between age groups. period. this is an encyclopedia; all that matters are the facts. Cindery 22:47, 30 September 2006 (UTC)

RegisA 00:47, 1 October 2006 (UTC) If you write back please at least talk about the points I have made as I have done for you point by point. In addition, if you think something I've mentioned is personal point it out. The statements I'm making directly refer to the legitimacy of including these papers and a summary text in the ECP article. Therefore, I don't see how they could be any more relevant (as opposed to personal). I think people can see that for themselves. You are correct in saying that one of the comparisons was between age groups but this was one of many. There was also a comparison between study groups (see Table 2 and Table 3 of paper) which is the basis of the argument that transitioning from prescription only access to over-the-counter is safe (this is a fact, not personal). This should be obvious if you had taken the time to read the entire article or read my comments. RegisA 00:47, 1 October 2006 (UTC)

Gentle aside: Remember wikipedia is not the place to actually debate out an arguement, but only to report on debates which have already occured outside in the real world. So if a study is flawed in its execution or the conclusions it draws from its own data, we can not ourselves so interpret and add into wikipedia, however "true" (see WP:NOR). Instead one must WP:CITE from external WP:Reliable sources that have made such points.

Hence "the legitimacy of including these papers" is not ours to make, if studies are substantial then they may be included, if they are problematic then cite an external source that so states. If the paper, despite being flawed, is substantial or influential (even if for "incorrect" reasons) then it probably should still be included with the opposing POV then covered: the phrasing in wikipedia might be along the approach of: "X looked into A and concluded B. Criticism of the study by Y suggest C".David Ruben 02:53, 1 October 2006 (UTC)

RegisA 16:15, 2 October 2006 (UTC) You stated that wikipedia is not the place to actually debate out an arguement. While this is true for the actual wikipedia article, I'm debating in the talk page (which is one of the main reasons the talk page exists) so I don't understand your point.

Your statement "the legitimacy of including these papers" is not ours to make could not be more wrong. Everytime you eliminated certain articles and included others were you not making such a choice? Misplaced Pages is a collaborative effort in which you or I can make such decisions. If the "legitamacy of including a paper" is not ours to make, then wikipedia would not exist. Think about it, if we can't make this decision than this discussion is pointless.

Now can we please debate the merits of the paper. If you think its flawed then how about discussing that. If you think the conclusions are in question, then talk about that. I agree a legitimate POV should be included if it is valid. Unfortunately, up until this point, you have not given any rational legitimate alternative POVs. The point of this entire discussion is to decide whether or not to include the descriptions/summaries into the article. I am saying that the article is not flawed (an opinion shared by experts and supported by other replicating studies) which is an opinion you differ with. This should be the point of the discussion we should be having. Your previous statements have offered nothing toward this end and have devolved to the point where you don't even directly refer to the paper anymore. Lets move foreward. RegisA 16:15, 2 October 2006 (UTC)

It seems like you have confused David Ruben for Cindery, and that you have not read closely what David Ruben has said. He specifically said: if studies are substantial then they may be included, if they are problematic then cite an external source that so states. If the paper, despite being flawed, is substantial or influential (even if for "incorrect" reasons) then it probably should still be included with the opposing POV then covered Which I took to mean that Cindery's criticisms needed to be referenced, and that these studies are probably substantial enough to be included, and if necessary/possible rebutted by other substantial studies. I agree strongly with David's understanding of policy and this situation. I hope this clears things up. As for debate, please read the disclaimer in red on the Talk:Creationsim page. We cannot do original research and reach conclusions here, we can only assess if sources meet the wikipedia guidelines for reliable sources.--Andrew c 16:25, 2 October 2006 (UTC)

RegisA 06:06, 4 October 2006 (UTC) Thanks Andrew, your right in that I did confuse Ruben with Cindery but at the same time I would have not altered my statements. Rubin (or Cindery) has not presented a valid alternative POV and I could tell this discussion was degrading to the point that the merits (or demerits) of the study were no longer being discussed. If they did, I would be fine talking about these points. Neither has offered an alternative POV or listed any external sources furthering such a point. At the same time, I have referenced other independant, expert, scientific, peer-reviewed commentary in support of this article. In addition, I have also pointed out other independant scientific studies converging on the same point. It is for this reason I fealt that Rubin's comments did not offer substantially to this discussion. Although I agree with his comment in general, I feel that this policy was not violated in this case and therefore irrelevant. Therefore, I think it is pertinant that either Cindery or Ruben state their alternative POV clearly and concisely. Otherwise, there is no reason for this discussion. RegisA 06:06, 4 October 2006 (UTC)

So what is the status of this dispute? It's been 2 weeks with no comments (but it also doesn't seem like Cindery has been on wikipeida at all this month). What needs to be done (if anything) for us to be comfortable removing the factual accuracy tag?--Andrew c 18:12, 20 October 2006 (UTC)

...sorry, i was called away by real world concerns. i haven't even read the newest version of the article yet, but having re-waded through the wordiness here, i'd summarize that:

the results of the studies show that the more access there is to EC (available over the counter etc) the more they are consumed--that's all. consuming more of them has not been shown to be of any value in and of itself (except presumably for the drug comapnies who profit from more consumption...) the darney/raine study was sorta hijacked after-the-fact to make argument that easy-access doesn't increase STDs/promiscuity, etc after the rightwing morality claims that access would increase promiscuity/STDs--frankly, i could care less about that (and probably too frankly, since my well-known position around the birth control-abortion articles is that i'm to-the-left of the left) i just find it irritating when criticism of pharmaceutical drugs is met with what appear to be assumptions that i am on the right/aligned with woodcock's moral "they'll have orgies if we give them EC!" position:-) so, my argument is that the darney raine study clearly shows more access=more consumption. it doesn't show that easy access means more consumption= good. and it doesn't show easy-access/more consumption results in less promiscuity/less STDS--because there was no non-EC control group. it shows only that there was no promiscuity/STD difference between age groups. my interest in making that plain--aside from factuality and neutrality--is that i think it's another misleading marketing claim that helps hype drug consumption/pharma profits. the "should be over the counter!" argument was hotly politicized--and for no good reason that benefits the public health/women. there's no benefit to over-the-counter availability, except that more drugs are consumed and sold--it hasn't lowered abortion rates, etc. (and darney is on the payroll at drug companies which manufacture levo--i've already complained elsewhere that his financial conflicts of interest viz levo are great enough that he shouldn't be cited as a source without that disclosure...)

barest summary: no control group means the only valid conclusion viz darney/raine study is there was no difference between age groups--it simply does not support the claim that EC use doesn't increase STDs/promiscuity in general. my moral position--irrrelevant, and i don't feel i should even have to state it but whatev, perhaps at least it will help regisA understand--is i could care less if it increased promiscuity. as far as i'm concerned, that would be cool if it did. bummer if it increases STDs. i think the "morality" firestorm was very contrived on both sides. (and the liberal position is more and more aligned with/usurped by drug company agendas). my position is I'm insisting that the results of that study be represented factually --because it's wikipedia policy. my ulterior motive/bias/POV is to undercut the drug company pro-consumption marketing...(and no, the long term effects of repeated high doses of levo as EC haven't really been adequately studied...) Cindery 09:01, 2 November 2006 (UTC)

abortion rates as measure of efficacy

I mentioned this before in reference to an earlier thread, but again: it seems inappopriate to focus on abortion rates as the ultimate measure of efficacy for EC. The number of things affecting abortion rates is astronomical. When a new antibiotic is approved, we don't demand a decrease in nationwide infection rates; we just demand that the antibiotic work in an individual patient. We don't demand that any other method of contraception lead to a decrease in abortion rates nationwide. Similarly, the measure of efficacy for EC is its effectiveness in preventing pregnancy in an individual person - which is clearly demonstrated in the literature. It would be great if it reduced abortion rates too, but that's a social issue much bigger than EC alone. The fact that abortion rates have remained constant or risen deserves mention, but not as some kind of condemnation of the effectiveness of EC or argument against OTC status. MastCell 19:03, 2 November 2006 (UTC)

if EC is not supposed to reduce unintended pregnancy/abortion rates, what is it supposed to do? That's precisely what it is supposed to do--reduce unintended preg rates that are result of reg birth control method failure, etc. The control group is a population that has access to lots of reg methods of birth control...not reducing abortion rates is a measure of "actual use" efficacy.

I think also there is still a fundamental misunderstanding re the studies and efficacy--taking it once means it has a certain percentage of efficacy used once--and that is a clinical situation, not reproducible in actual use. the directions say, "do not use as reg method of birth control." in between, is the actual use area--epidemiological studies show that in actual use, the more access there is to ECP, the more it is consumed. it's not hard to imagine people doing the guesswork on whether maybe they should take it. here's this drug--maybe you were ovulating?...should you take it if the condom broke and you think you were ovulating, or should you take it just because the condom broke??...over the course of a fertility cycle, this decision is easily pondered more than once...over a a course of 12 cycles, who knows how many times? in the end, people with access to all birth control methods + ECPs are not better off viz unintended pregnancy than people only with access to all methods of BC...the unnatural clinical circumstance--one instance of sex + one instance of ECP use-- is a measure of perfect use efficacy not just for the drug, but for the people who will use it. people do not have sex once a month. i agree, as lyrl pointed out, this makes calculating efficacy for ECP unique and confusing. but in this case "people" as a variable (meaning, "people" as the variable in an effficacy study for the pill means "people" can refer to "poor compliance" etc regarding efficacy, and therefore disregarded viz "perfect use")--in this case, "people" as the variable can't really be disregarded. or at least it should be made clear that "it's <blank>% effective!" means it's blank% effective in your body once if you only have sex once--not magically blank% effective if you are regularly sexually active and have access to it. Cindery 19:30, 2 November 2006 (UTC)

You're conflating two arguments. ECP is supposed to reduce the chance of a woman conceiving after an episode of sex; there is evidence that it does so. ECP is not inherently supposed to lower the nationwide abortion rate, nor the aggregate rate of unintended pregnancies. No method of contraception in history has been statistically proven to lower the rate of "unintended pregnancies" or abortion on an aggregate scale, nor do we demand such proof. All of your conjecture about the difficulty of knowing when or how often to use it is valid; however, none of it means that ECP should not be available as an OTC option. People have sex more than once a month, but it's conceivable that once during that month, regular methods of contraception may be forgotten, unused, etc. ECP is for such a niche. It's not a panacea and it's not going to reduce nationwide abortion or "unintended pregnancy" rates. Those would be unprecedented and unrealistic endpoints for any method of contraception. MastCell 19:48, 2 November 2006 (UTC)

• I'm not conflating two arguments--I'd addressing the two separate arguments you brought up (perfect use/actual use).

• Nowehere am I making or have I ever made the argument in any way that it shouldn't be available OTC. (I cited the study that it doesn't make any difference if it's available OTC or not. I think people should have free access to it--but the article can't claim OTC equals anything than more consumption--those are the facts. My irrelevant opinion is that the whole self-righteous moral issue on both right and left sides re OTC is a huge red herring. I do not endorse OTC access as a holy war of left v right. People should have whatev access to it; the article can describe the real-world debate about that via sources. the study that cites that OTC makes no diff is factual, neutral. Yes, I am happy if it makes people think twice about mindless consumption and how political debates can be so much hot air, but what I'm happy about doesn't matter--I'm just making my POV clear since it has been misunderstand more than once, in hopes of focusing discussion away from POV and toward facts, sources, etc.

• No method of contraception in history has been statistically proven to lower the rate of "unintended pregnancies" or abortion---this is where I think you're misunderstanding. EC is not a form of contraception--it is specifically not supposed to be used as a form of contraception (because it has been shown to be an insufficently effective one, among other things). It's raison d'etre is to reduce unwanted/unintended pregnancy as a backup for BC. If it can't do that--show a diff in abortion in pops with full access to BC and EC--it's just highly profitable toxic junk, IMHO. There's a huge POV push in this article to promote EC. I spose I;m the devil's advocate, saying, er, ok, I see what's in it for the drug companies--what's in it for women :-)?

Cindery 20:34, 2 November 2006 (UTC)

...perhaps simplest way to summarize difficulty of calculating perfect use efficacy rate of EC is comparison of calculating this with how perfect use is calculated for a BC method, like the pill--the clinical circumstance of perfect use of pill is reproducible (and very easily reproducible) in real life: remember to take the pill everyday. the perfect use clinical circumstance of EC is pretty much "try only to take it once a year or something, by um, guessing if you should." Cindery 20:49, 2 November 2006 (UTC)

Er... ECP is a method of contraception. Hence, emergency contraception. It's a last resort, granted, and should not be used first-line for all of the reasons you mentioned; still, it is a form of contraception and should be evaluated as such. What do women get out of it? I guess a 50-75% chance of avoiding pregnancy if ECP is taken as directed. I don't see any attempt in the article to whitewash concerns over effectiveness, nor to present ECP as a panacea or 100% effective. I'll say this again: abortion rates are an entirely inappropriate endpoint to gauge its effectiveness. You're conflating ECP's effectiveness in a individual with its ability to effect a major societal change by reducing nationwide rates of abortion. Your argument that "ECP doesn't do anything because abortion rates don't change" is misguided and holds ECP to a standard that no medication or contraceptive measure has ever been held to. MastCell 21:27, 2 November 2006 (UTC)

ECP is "emergency contraception," not "contraception"--two separate categories. It specifically states in all the prdduct info that EC should not be used as contraception. There is a crucial distinction between contraception and emergency contraception--contraception is supposed to be used regularly, EC is not. This crucial distinction pertains precisely to evaluations of efficacy--contraception is supposed to prevent unwanted preganancy. Emergency contraception is supposed to prevent the unwanted pregnancies contraception can't prevent--EC is supposed to fill in that gap. If it doesn't, that's extremely relevant to it's "actual use" efficacy.

(Also, I think you are confusing two separate arguments--there are two separate ongoing threads 1) "perfect use" and how to state it in the beginning of the efficacy section, and 2) whether or not the abortion stats from China and Europe should be in efficacy section, or if they should be elsewhere. I have addressed both arguments in our discussion, but they are separate issues in the larger discussion/the article.) Cindery 22:14, 2 November 2006 (UTC)

...also like to add--in interest of directing conversation away from opinion and back to cited sources--it is not merely my opinion that EC availability and abortion/unwanted pregnancy rates are related qua efficacy/overall usefulness--the cited sources specifically make the association. They are studies specifically of whether or not EC access makes a diff in lowering abortion rates/is useful for its stated purpose--the European one by the same EC expert cited elsewhere in the article.. Cindery 22:26, 2 November 2006 (UTC)

You must mean Anna Glasier. I'm glad you trust her... she's received grant money (="been on the payroll"?) from Schering, marketers of EC in the U.K. (see her editorial in BMJ that was cited in the Forbes article). You gave poor Darney such a hard time for taking pharma money; I'm glad the distrust doesn't extend to Dr Glasier.

The authors address those issues because for awhile there's been a belief that increased EC use would decrease abortions. As you point out, that hasn't been borne out in the literature. The question of whether EC "does anything" or "fulfills its stated purpose" is a different one. Glasier makes the point, in her editorial, that if you're a woman who just had unprotected sex, broken condom, etc, then it makes sense to take EC because it will lower your rate of concpetion. However, if you're a public health entity, it doesn't make sense to push EC as a solution to the societal issues of abortion rates, unintended pregnancies, etc.

I guess to bring it back to the article, we're not really that far apart. I agree mention should be made of the failure to document lower abortion rates. However, I got the sense that you were arguing that OTC status is a ploy by big pharma (in cahoots with Planned Parenthood) to get more people to use an ineffective med, and my point was that the medication has met the standard bars we set for efficacy and safety. That's all. MastCell 23:33, 2 November 2006 (UTC)

i haven't made the case at all that Darney should be tagged with conflict of interest here (though perhaps he should. What esp. bothers me about him is that I do think his conflicts of interest matter--I've never seen anything critical written by him re drugs he is paid to flack. and he doesn't merely get grant money--he's on the "speaker's bureaus"--he really does actually flack. Also that he is in charge of *the* big long-term epidemiological safety of levornorgestrel itself in San Francisco right now--I don't expect that to tell us anything other than "it's awesome!" :-) An easy argument can be made for Glasier that her potential conflicts of interest don't undermine the scientific integrity of her research--she has been openly critical of ECPs when her research indicated.

I think your point re individual woman v. public health policy is a good one, but, i amthinking from the perspective of the "individual woman," --and imagining the readers of the Wiki EC article to be "individual women" looking for reliable info, trying to decide if they should take it. Let's compare our EC article to the current news re lung scans--these scans can detect cancers early. but there's a risk of lung puncture, and 80% of cancers at that early of a stage resolve themselves. On the other hand, lung cancer is the most lethal cancer, esp when not caught early. there are good reasons to get the scans, and good reasons not to--given the facts, come people will choose them, some won't--the pros/cons are being presented fairly straightforwardly to the public. Not so ECPs (not in US, anyway, and definitely not lately...) they have been presented as a left v right issue, not a consumer medical issue. period. no one is asking, hmmm, what are the pros and cons? anyone who mentions cons or puts inflated pros into perspective is treated as a political foe...Wiki should have an NPOV fact and source based article. (It has grown/improved considerably from being a mere recounting of the debate to approve OTC sales and an argument between left and right over whether EC is abortifacient. But it has a ways to go before it's a useful encyclopedia entry for a general reader about ECPs...)

Re big pharma, i want to add a "Marketing" section to the bottom of the article noting a USA Today article (among other things) which quotes Duramed (division of Barr which markets Plan B): "In anticipation of the approval of OTC Plan B sales, Duramed designed a single container that has 'visual appeal' for consumers." and: "Duramed expects that OTC approval will double Plan B's annual sales." I don't see any big "conspiracy" in OTC--but i do see big money for Duramed (and so does Duramed!:-) and no clear advantage to women--OTC just means they take more (likely superfluous) doses than women who need a prescription. And I see more patients and hence more dollars for PP. I do think PP made/helped make a "moral" issue out of OTC to incite people against the rightwing--blowing pharmacist conscience thing out of proportion, milking it for animus when it was pretty small potatoes. When you're incited against the "enemy," you don't look so critically or closely at what the enemy is "against."

"The medication has met the standard bars we set for safety and efficacy" describes plenty of drugs which are later shown to be neither safe nor sufficiently effective; and "we" are not the FDA...(I noticed someone tried to bury first ECP--high-dose estrogen DES, unwikified it even...) But, sorry for sidetrack--back to article/sources... Cindery 04:37, 3 November 2006 (UTC)

I agree with most of your points; I just don't see things in quite as sinister a context. Every OTC med is designed to be in a "visually appealing" package, and OTC status definitely improves sales. I do agree with Jfruh's points about PP - I'm not clear how making EC OTC will make PP any more money, and I think PP's motivation is based on their political convictions rather than pecuniary interests in this case. These things can of course be mentioned, but strongly implying a sinister motivation behind them probably violates WP:NPOV. By "we" above, I guess I meant the FDA (our governmental representative when it comes to evaluating safety and efficacy). Is the FDA perfect? Of course not. But their evaluation carries quite a bit of weight. MastCell 18:06, 3 November 2006 (UTC)

Again, "sinister" and "conspiracy" are not words I have used or implied--I have clearly implied via "smiley face" that i see pedestrian capitalism of the most pedestrian sort, not a "sinister conpiracy"--yr accusations almost border on WP:NPA, and I hope you can refrain in future. The point of a "marketing" section is that it's an excellent counterpoint to systemic bias re depicting ECPs/OTC is a left v right issue--very useful for readers to be reminded it's not just a subject which has been contested by left v right, but a pedestrian consumer medical issue, too-- a consumer medical issue which includes marketing and profits. Barr is not manufacturing Plan B because they care about anyone's health or women's reproductive rights--they're doing it because there's money in it. It's an excellent reminder, and as long as there's such an emphasis on politics and OTC in the article, it belongs-- for balance. As for PP, do you know what Title X funding is? and, more importantly, as I mentioned, any cited rebuttal more than welcome re the citation that they have a conflict of interest.

Re FDA--it's not just that it's imperfect, it's under a lot of heat lately, as I'm sure you're aware (Vioxx, etc). But the main point I made re "what FDA drug approval means" was DES--DES is a reminder (and probably for a lot of readers, an education in the first place) that the FDA has approved hormonal drugs for women which had tragic consequences. I am suspicious that unwikifying DES was POV-pushing of a sort (I haven't checked edit history--I dunno who did it or what reason they gave...) It is precisely because FDA approval "carries a bit of weight" that, for balance in the article, readers are invited to think about other, similar drugs FDA also approved...Note that no anti-FDA argument is made in article, nor any FDA controversies mentioned or brought up in article--DES was merely mentioned in history of ECPS (where initially Yuzpe was incorrectly cited as first ECP) and wikified... Cindery 20:21, 3 November 2006 (UTC)

Please don't put words in my mouth. I don't recall saying anything about a "conspiracy"; that was your word. Also, please don't throw around accusations of personal attacks. Stating that you've implied a sinister motivation is not a personal attack; it's a comment on the content of your posts. You've implied repeatedly that EC is an ineffective/unproven treatment being pushed OTC by Barr and PP to make money. You've implied that PP cynically milked the political controversy for its own financial gain. You've implied that a drug company putting its medication in a "visually appealing" container is noteworthy. You've also stated that you believe de-wikifying DES was done for sinister reasons, without looking into who actually de-wikified it or under what circumstances. Pointing out that these are implications of sinister motivation is not a personal attack; please review WP:NPA. I think you're generally reasonable and you've made excellent contributions to this article and the talk page. But please don't throw around charges of PA's over a disagreement about context and content. MastCell 21:31, 3 November 2006 (UTC)

You said: I got the sense that you were arguing that OTC status is a ploy by big pharma (in cahoots with Planned Parenthood) to which I replied, "I don't see any big 'conspiracy,' but I do see big money for Duramed, and so does Duramed! :-)" So I suppose that would be a rather tedious semantic argument--is "a big ploy in cahoots with..." equivalent to "conspiracy" I'm gonna go with yes. Mischaracterizing my point that, according to the manufacturer of Plan B, OTC access is going to double their sales as accusing them of conspiracy is not appropriate--I do think you're responding with personal attack/ad hominem. As for "sinister," you have said it here: I just don't see things in quite as sinister a context. here: was done for sinister reasons and here: strongly implying a sinister motivation--the second time with an unfounded NPOV accusation, as well. Pointing out that these are implications of sinister motivation is not a personal attack is absurd--making any such allegation is your opinion, not a statement of fact. It is also derogatory, not helpful, and a rather transparent attempt to avoid discussing points/issues by personally attacking one's "opponent" instead. I hope you can cool off and remember that "Misplaced Pages is not a battleground," and that I am not your "opponent." Stating that your opinion that I see a "sinister" context--after I have said I see systemic political/POV bias and pedestrian capitalist self-interest--does verge on personal attack (and is definitely not assuming good faith...) Cindery 21:58, 3 November 2006 (UTC)

Characterizing your arguments as implying sinister motive is not an ad hominem attack. It's focused on your arguments; how can it be ad hominem? You put the word "conspiracy" in quotes as if I had said it, when I had not. That's all. This is the talk page; of course what I say here is "my opinion", not necessarily a "statement of fact". The talk page is a forum for opinions (as opposed to the article itself).

You say "systemic political/POV bias and pedestrian capitalist self-interest"; I say those are "sinister motivations" - since we're talking about a public health intervention, such motivations would be somewhat sinister. Again, you've argued that:

• EC is an ineffective/unproven treatment being pushed OTC by Barr and PP to make money ("i do see big money for Duramed... and no clear advantage to women--OTC just means they take more (likely superfluous) doses than women who need a prescription.")
• PP cynically milked the political controversy for its own financial gain. ("I see more patients and hence more dollars for PP. I do think PP made/helped make a "moral" issue out of OTC to incite people against the rightwing--blowing pharmacist conscience thing out of proportion, milking it for animus when it was pretty small potatoes.")

I summarized those arguments as implying a sinister motive, and stated that I have a different opinion about them. Please address those arguments and correct me, if necessary, without resorting to accusations of PA's and ad hominem attacks. As far as assuming good faith, you've leveled the accusation that DES was de-wikied out of POV-pushing, without bothering to see who dewikied it or under what circumstances. I really have no desire to fight about this stuff; I don't feel that strongly about it and I'm averse to conflict. Your advice to me to "cool off" is appropriate, and I'll try to do so; I'd ask you to try the same. MastCell 22:34, 3 November 2006 (UTC)

No, the talkpage is not actually supposed to be a forum for opinions--there's a "please stick to issues pertaining to changes in the article, not discussing the subject in general" template, in fact, that should maybe be placed on the talkpage of this article. Viz "opinions," There are diff schools of thought about "revealing one's POV"--some people feel fine about stating theirs/some don't. I find that it can save time by stating my POV sometimes, as even editors I have tremendous respect for, such as David Ruben, was initially suspicious that my attempts to "include cons/put pros in perspective" meant I might agree with Woodcock about morality/orgies and EC. Unfortunately, people who say, think OTC access was a moral issue are still offended by question-big-pharma POV, but at least others stop leaving huge diabtribes on my talkpage that should be sent to the Republican HQ, not me. :-)

"impying a sinister motive" leaves out a pronoun--who is implying the sinister motive? Uh, you are saying it's me--that's ad hominem. Let's let it go, and in future please take care to address my proposed changes/arguments for proposed changes directly, without verging on personal attacks, etc.

Addressing what you have said which pertains to changes in article:

• 1. pharmacist controversy involved 2 pharmacists--original text implied it was a much bigger deal than that, citing PP as source.

• 2. Crenin clearly states that some women would not get pregnant anyway even though they took EC--it is obvious some doses are therefore superfluous/the impossibility of knowing if fertility is in effect makes superfluous dosage an inherent fact of EC use.

• 3. Because OTC access means more usage but not necessarily more prevented pregnancies, greater access/OTC access=more superfluous doses.

• 4. I phrased DES unwikification very conditionally "I am suspicious that it was POV motivated," etc. It does seeem that anything critical of EC was deleted/trivialized etc in my month-long absence...

Cindery 23:12, 3 November 2006 (UTC)

Some thoughts over these points:

• Yes I believe ECP will prevent pregnancy in some women, indeed in the majority if (and what an if) taken when appropriate (i.e. correct time of the month and with regard to a specific exposure event).
• Yes it is a form of contraception, in as much as to prevent pregnancy vs. eliminating an established pregnancy (I follow the pre-implantation = contraception, post-implantation = abortion view point).
• No it is not a form of routine contraception, but for "emergency" use only
• No I don't think overall abortion rates are the best measure of a specific type of contraceptive. There will be those who did not use this or any for of contraception who become pregnant and request a termination. There will be those who used another method of contraception yet still became pregnant. Even for those who used EC there will be both those who used it incorrectly/inappropriately and some for whom despite correct usage they none-the-less conceived.
• EC and Abortion rates are clearly not unassociated, but they are not causally linked. One might compare abortion rates against national income, house ownership rates, sales of telephones. Clearly these are not causal issues.
• The above list of items are though also associated and indeed probably not randomly so. With higher income/education/society changes with personal freedoms, so one is dealing with "modern" developed societies for whom yes contraceptive options are wider, abortions are technically available (sterile operating rooms, anaesthetics, access to medications), but also more liberal (with lowercase "l") laws that permit abortion at all, and finally greater is the acceptance/willingness for women to make use of this (less moral/religious absolute objection).
• The last point though is moving away from a purely clinical issue of a women, an event, an administration of EC, to instead a social assessment. Hence:
• Yes I think the recently widely reported findings of increased abortion rates despite inc EC use do need to be included in wikipedia.
  1. The wide reporting in itself made the issue notable.
  2. It is an indictment of overall health policy & implementation, rather than a direct reflection on any single (or several) contraceptive measure(s). Hence abortion rates might be blamed on poor or ineffective sex education at encouraging safer practices (whether this is state education via schools or advertising, parental instruction being effective or "society" attitudes refelected by TV, books, teen journals etc).
  3. If governments or health departments announce that they wish to make EC more directly available (via pharmacies) to help reduce the rates of pregnancies/abortions (as they certainly did in the UK), then that public health policy may reasonable be held accountable by measuring the rate of abortions. Persobnaly I think it is good that they are so available, but on basis of convenience/choice for the women (vs some misogynistic society dictating to women what they may or may not do), but abortion rates unlikely to change unless a change in society or at least a change in individual attitudes within society occurs.
• Yes therefore mention abortion rates despite introduction of public stated polices on EC, but no this is a poor assessment of EC inherent perfect-use effectiveness, but more an indictment of governments not ensuring adequate public understanding of routine contraceptive usage, routine contraceptive availability (e.g. of the Family Planning clinics which run independently of ones own General Practice), awareness of when EC is appropriate and (to give credit to arguments above) that EC is not a substitute for more responsible behaviour (i.e. to think in advance re sexual practices, need condoms to stop STD spread and routine contraception).
• So cite the reported story of "Increased abortions despite increased EC", but also cite the critisms of this study that were also reported in the newspapers. The article needs to distinguish between EC use in an individual and the wider social aspects of EC usage, were I a women whose condom had broken then yes I would use EC, but if as the same women I was also a Health Minister, then no I would not advocate or claim that just making EC avaiable in every corner shop (? = general store in USA) would on its own have much/any effect on abortion rates. David Ruben 13:25, 5 November 2006 (UTC)

I agree with David 100%. MastCell 17:52, 5 November 2006 (UTC)

Delinking of DES

When I am writing a new section (such as the History section on this page), I often have open research articles, web sites, lists of Google search results, User:Diberri's PubMed tool, my edits (often in preview mode), and the original article (not in edit mode). I copy and paste from all windows into the edit pane as well as typing things out. I'm sure what happened was that I copied the sentence with DES in it from the article (not in edit mode) into my edit window. So the wikilink markup was not transferred. And with the other edits I was doing, I missed that I needed to re-markup DES.

I assume that the apparent good-faith nature of my edits caused other editors to not scrutinize it too closely. And the major nature of the edits made it non-obvious that a wikilink had been lost. Here is the diff - note that this was all one edit, not a series of smaller ones.

It is disheartening to see that the only reason an editor can think of for the de-linking of DES is censorship, a POV effort to downplay the drug's history. Even more disheartening that an editor thinks that not only would such vandalism (removing relevant information from Misplaced Pages articles is vandalism) be done - but that it would be tolerated by every other editor that watches this page. It can easily be interpreted as a harsh indictment of the entire Misplaced Pages community. I know it's not meant as an attack, only as commentary on the article - but it is difficult to not take it that way. Lyrl _Contribs 16:17, 5 November 2006 (UTC)

I don't think--nor did I say it was "vandalism"--I said "it does seem that anything critical of EC was deleted/trivialized in my month-long absence," including DES de-wikification along with:

• moving abortion rates citations not just from subject of efficacy, but to the bottom of the article ("confusingly buried in a jumble of disorganized factoids"). No argument or justification was made for this move, until it was challenged by me/no one else challenged it. (Even among the most standard/oft-repeated/pro-EC descriptions of "efficacy for EC," it is usually mentioned in the first sentence some variation of: "could reduce abortion rate by significant degree."--linking abortion rate reduction and subject of EC efficacy.)

• the persistent restatement of the darney/raine study without objection from anyone as a justifation for the claim that EC does not increase risky sexual behavior in general, when it can only support the claim that it one study, it did not show a difference between age groups/advance access/and risky sexual behavior.

I would also say that included under "deleted/minimized" (but not specifically addressed yet) is:

• significant expansion/lengthening of OTC controversy in US which minimizes/buries study (there is more than one, actually) which states that OTC access/advance provision of EC results in more usage but not fewer unwanted pregnancies. The weight given to pro-side of pro/con OTC access controversy is undue in relation to weight given critical source. (I think the weight is also undue re "recentism" and US-centric--it should probably be under a different section, like "US legal controversies," not in "availability," and summarized much more succinctly. Perhaps it is interesting enough subject for its own article?--in that case article would also be summarized here/not reproduced at length.)

• DES was not just unwikified and the correction made by no one, but moved from "types of ECPs" to a new section called "history," much further down in the article, where it is stated that a large number of things were studied as ECP (when the majority/commonly accepted information/given is that DES was the first/first recorded. There is only one source which says "cytotoxics, metabolites" were considered, and no info is given about them. I don't think the citation supports claim of "large number"--it's a handful, and it minimizes DES as first. There are not a lot of types of ECPs, and high-dose estrogen/DES is still used in some parts of the world on the 5/5 regimen--I'm not sure a history section is really necessary as there are so few types. Certainly the standard history sidebar elsewhere lists all forms of ECP used + years first used DES 1967; Yuzpe 1973...etc., it doesn't list any "also-rans" or claim there were a large number of them. (There was douching with coca-cola, and the history of EC outside of approved prescription drugs and devices dates back to silphium and pennyroyal--a history section which addresses things that were never approved and are not in use now nor mentioned elsewhere in the article would seem to me to begin with silphium, pennyroyal etc, and go on to mention coca-cola, whatever is meant by cytotoxics and metabolites, etc., while the approved medical types of EC currently/recently in use would fit under "types of EC." While I think this was a good faith edit on your part, I also think it minimizes a critical implication, and that apathy about restoring critical info is not uncommon in POV-unbalanced articles.)

I did say specifically that "there's a huge POV push in this article to promote EC"--and I do think it's not an unfair assessment to say that this page is generally watched and edited by editors who are interested in maintaining the most favorable impressions of EC possible, or have a mere "recentist" bias re Plan B they may not self-detect, which results in reiteration of what has most recently been in the news about Plan B or the most recent information given about Plan B. (There is a discrepancy between the standard information given about EC between, for example 1998 and the present. Such information--24% annual failure rate--the same as doing nothing--has not changed since 1998. What has changed is that it's not on the Plan B product insert...) The only critical element which seems to be not introduced by me is the persistent reintroduction of the idea that EC is abortifacient. (And I think undue weight is given to that controversy. My initial edits to this page noted the clear factual innacuracy regarding mifepristone and abortifacience in the article, and these edits were met with group resistance. Even Plan B marketing materials note that "Plan B is not RU-486," not that ECs as a broader category which includes mifepristone cannot be abortifacient.

In summary, I think there's a strong recentist overemphasis on Plan B, and on depicting it and the political arguments in favor of it favorably in this article, and work could and should be done to improve quality of the article by improving the neutrality of it. esp. viz pro-Plan B on political grounds and recentism re Plan B. I don't think stating this rises to the level of "an indictment of the entire Misplaced Pages community," as I have not even flagged the article for POV, but merely initiated discussion on the talkpage.

Cindery 18:28, 5 November 2006 (UTC)

I think Lyrl was just saying that we all need to make an effort to assume good faith (I'm no exception). I don't really see any POV warriors among the frequent editors of the page. The Plan B controversy is relevant to emergency contraception, and it is toward the end of the article, under "U.S. Availability" (i.e. not given undue weight). For instance, it appears behind the assertion that Planned Parenthood has a conflict of interest, arguably a less relevant claim, and equally regional and "recentist". (and a claim of "controversy" where no citation is provided of someone alleging said conflict-of-interest is OR - I don't doubt the allegation has been made somewhere, but we need to cite a source alleging controversy. Right now the cite is just to the PP page.)(Actually the cite is appropriate and it is not OR; struck comment was based on my misreading.) It would be fine to expand the section on DES, but DES has its own article and is no longer in wide use in the English-speaking world as EC, so the section would necessarily be of primarily historic interest. Cindery has some good points about content of the article; I think Lyrl was just asking that we all try to assume good faith - that is, in this instance, instead of voicing suspicions about POV-pushing, rewikify the link and assume the more innocuous explanation, which appears to be the correct one. MastCell 19:58, 5 November 2006 (UTC)

You can "cross out" the PP cite/OR accusations above, so they appear but, as a cross-out, with mention of your edit summary. Or you can put a placeholder, with the indication "redacted" + your edit summary, if you want to delete something you wish you hadn't said, and no editors object. I prefer the cross-out at this time, and object to redaction.

Re DES: no one has proposed a section/word was re-wikified by me. Cindery 23:36, 5 November 2006 (UTC)

Subsection for readability

To me, it makes most sense to have technical information at the top of the article (what is currently available as emergency contraception - including IUDs! - how do they work, how effective, etc.) And then discuss less technical aspects. I thought the order of "History" -> "Effect on society" (sexual behavoir, unplanned pregnancy, abortion, etc.) -> "current controversy" produced the best flow. I wanted all of these sections after the IUD section, because these three sections all apply to all types of EC, including IUDs, and so make best sense if they appear after the "types of EC" section.

The Darney/Raine study showed that ready access to ECPs did not increase risky sexual behavoir above that of women with prescription access to ECPs. No, this is not related to populations that have no access at all to ECPs. But it does say something about ECP effect on sexual behavoir, and is relevant to the section on sexual behavoir, unplanned pregnancy, abortion, etc. which is currently titled "Abortion rates".

A section getting too long for the main article is practically the reason for Misplaced Pages:Summary style - This guideline in a nutshell: When articles grow too long, longer sections should be spun off into their own articles and a several paragraph summary should be left in its place. In Misplaced Pages, topics most interesting to editors are developed first, regardless of importance. So early Misplaced Pages, for example, was largely about Star Wars, due to high volume of science fiction fans among editors. Interest in Star Wars was so high amoung Misplaced Pages editors, that they created their own Wiki: Wookieepedia. And controversial topics in America get undue attention because most editors are American and have knowledge on those topics thrown at them, as opposed to having to do research. This tendency has been noted as a shortcoming of Misplaced Pages in every major third party discussion I have read. I do not understand why this natural growth pattern of Misplaced Pages ("reiteration of what has most recently been in the news") is viewed as a deliberate effort to hide (minimize, whatever) other information.

The same characteristic of Misplaced Pages means many editors are unaware than Plan B is not the only form of EC. Mifepristone is actually a recent introduction to the EC article; before the edits by Calair in July, I myself had never heard of such a use for mifepristone. I think it inevitable that it will take time to update all the remaining parts of the article written when Plan B and Yuzpe were still the only regimens included.

The history section was based on my search of PubMed. I find the research history of hormonal ECPs, not just which drugs were approved, very interesting. However, if other editors agree that only the approved drugs are interesting or relevant, and that all mention of researched but never approved drugs should be deleted, fine. Including mention of herbal methods as first EC and having a history section hatnote linking to the abortifacient article actually sounds like a good idea. The spermicide article also has a reference to an article that discusses various post-coital methods (all ineffective) used in early 20th century (Lysol was actually the most popular, above Coca-Cola). That information also sounds like a good candidate for incorporation in the history section. Lyrl _Contribs 01:32, 6 November 2006 (UTC)

I do not understand why this natural growth pattern of Misplaced Pages ("reiteration of what has most recently been in the news") is viewed as a deliberate effort to hide (minimize, whatever) other information --I don't think recentism/writing overlong sections in one's own interests is a deliberate attempt to "hide" anything--I do think it's not always representative of just of personal interest, though, that political POV is an issue as well if the subject is political--OTC, for example, is a political subject about which people have strong views. That makes it harder to get people to acknowledge that an overly long section is overly long/being given undue weight. I tried to edit it down before, it was expanded again, no other editor has pointed out that it's too long, etc. But the fact is, it's too long--I shouldn't have to be the only one to point something like that out, on a page that gets as much traffic as this one...I think it's a collective problem for this article, not a problem brought about by the personal interest of one or two editors in a subject. Cindery 04:05, 6 November 2006 (UTC)

(addendum: I did include OTC expansion as minimizing of study citation that OTC access does not reduce unwanted pregnancy. I originally shortened the OTC section, and put in the counterpoint--then I came back to find section significantly longer, with the one sentence study summary completely buried, not offering counterpoint at all. But that's two points: its excessively long; excessive length buried any counterpoint.) Cindery 04:39, 6 November 2006 (UTC)

If no other editor has raised the concern that the section is too long, then rather than an oversight on their parts, it may be that your opinion is not shared by other editors. The controversy over approval is part of that social impact of EC. There doesn't seem to be enough there to warrant its own article, so at present it should stay here. It's toward the bottom and unobtrusive. I'm happy to take a shot at shortening it for better readability. I think the history section is worthwhile and can be expanded, especially if Lyrl has already done some background on this. MastCell 05:11, 6 November 2006 (UTC)

No, it's prima facie too long--when any section on a peripheral subject becomes the longest in the whole article, it's too long. I believe that is what Lyrl was referring to when she mentioned summary style above. At least five pages could be written on all the complexities of efficacy, or history, or types of EC--note that the sections are abbreviations of tremendous amounts of information. The OTC controversy is not a summary of its subject matter as those more relevant sections are. And it's a US legal controversy--we have a section for it, where it could be summarized in a paragraph. Cindery 06:37, 6 November 2006 (UTC)

OTC controversy

Sorry, but I disagree...and I think it's obvious on the face of it--the OTC controversy is the longest section in the whole article, longer than than any section on EC itself. "Undue weight" isn't just about location, but length, and how much detail is given. The OTC section is a detailed, narrative account. It's slightly longer/more complicated than the "beginning of pregnancy" controversy section--and that controversy is complicated to summarize, and has existed longer/involves more people, worldwide. The OTC controversy, as I said, is a fascinating story, but peripheral to the subject of emergency contraception in general, and could probably have its own article. But in the EC article, it should be summarized, briefly, under "US legal controversies, etc"--in summary form, it would still appear as chief US legal controversy. (In "availability," its summary would require even more brevity to be comparable to info given for other countries--became available in such and such year. Cindery 21:34, 5 November 2006 (UTC)

My edit of 30-Sept

• I moved the "International availability" section to the bottom of the page (right above the "Footnotes" section).

• I added a history section. Some of the information I added (based on searches through PubMed), other information was moved from the "Types of ECPs" section.

• The reference link in the IUD section was broken due to PP's website reorganization. I could not find a comparable page in the new website, so changed the reference to a journal article I found through PubMed. I changed the wording in the IUD section to match the new reference.

• I renamed "Related statistics" to "Social impact" and moved it up above the controversy section.

• In the "Controversy" section, I changed a "see also" directive at the end of the section to a template at the beginning of the section.

In the "Effectiveness of ECPs" section:

• • I deleted the reference to a single act of intercourse, and changed the phrase "each use" to "single use" to attempt to clarify what is meant. I believe specifying a single act of intercourse in one menstrual cycle/month is not necesarily relevant. If a couple has intercourse many times with an ongoing contraceptive method, and then has a condom break during one act of intercourse - they may use ECPs and expect the normal effectiveness rate, even though they had intercourse multiple times that menstrual cycle/month. Also, if a couple has unprotected intercourse multiple times in a 3-day period, they can still use ECPs in accordance with the package directions (i.e. begin treatment within 72 hours of unprotected intercourse), and would seem to be able to expect the same effectiveness rates as couples who used the pills after only one act of intercourse.

• • The characterization of the studies on levonorgestral ECPs seemed to be inaccurate. First, the article stated that only two studies had been done. A PubMed search with the terms "levonorgestral emergency contraception" gives 211 results. While not all of those studies give effectiveness rates, it seems unlikely that only two of them address effectiveness. Second, the article stated that women in the studies had intercourse only once that month. The studies actually do not report how often the women had intercourse, only that they presented requesting postcoital contraception.
  • I broke out the section on variable fertility rates and tried to explain it a bit more in relation to ECP effectiveness rate calculation. I also removed references to coital frequency of study subjects.

• • I used User:Diberri's PubMed tool to convert a journal reference to the citejournal template.

• • I deleted a duplicate sentence on effectiveness range.

• • I moved the section on abortion rates to the "Social impact" section (renamed from "Related statistics").

Lyrl _Contribs 02:26, 1 October 2006 (UTC)

Social impact - Sweden

Removed the following inaccurate and misleading statement that misrepresents its reference:

In Sweden, teen pregnancy and sexually transmitted disease infection have increased since emergency contraception has been available over the counter. PMID 12407239

• Emergency contraception (Norlevo) first became available without a prescription in Sweden in April 2001 (behind-the-counter from pharmacists at launch, subsequently dispensed over-the-counter in some pharmacies). PMID 12954524

• The teen abortion rate in Sweden rose from an all-time reported low of 16.9 per 1,000 women in 1995 to a cyclical high of 25.5 per 1,000 women in 2002 and has subsequently declined for three consecutive years to 24.3 per 1,000 women in 2005 (the rate declined from an all-time reported high of over 30 per 1,000 women in 1976 to a cyclical low of under 18 per 1,000 women in 1984 before rising to a cyclical high of 24.9 per 1,000 women in 1989).

Note: the source cited here is completely in Swedish, but you can locate the database it links to and read summaries in English. Anon has left out the 2005-2006 data, which states:

Abortions in Sweden 2005. January-june

Preliminary report

The rate of induced abortions per 1,000 women during the first six months of 2005 was constant (20.3) compared to the same period 2004. However, the rate among teenagers increased by four per cent from January through June 2005 compared to the first six months of 2004.

Abortions in Sweden. January-june

Preliminary report

Summary

The total number of induced abortions performed during the first six months of 2006 was 17,910 compared to 17,499 during the same period last year. That means that the rate per 1,000 women increased by 1.5 per cent. The rate among teenagers increased by close to two per cent from January through June 2006 compared to the first six months of 2005.

Regarding cyclicity, what the Swedish source states is:

"There has been considerable change in the age distribution among women who obtain abortion after 1975. The number of teenage abortions decreased markedly between 1975 and 1985. After 1985, teenage abortions increased, but after 1989 teenage abortions decreased again, up until 1995. A small increase started in 1996, which has now accelerated to a more serious increase in 2002." --that means that the huge increase coincided precisely with OTC EC availability in Sweden, declined only slightly from serious high for two years, then resumed its present increase.

Cindery 11:00, 4 November 2006 (UTC)

• Reported genital chlamydia infections in Sweden decreased from 38,000 in 1988 to 14,000 in 1994 then increased to 33,000 in 2005 before decreasing in 2006.

68.253.189.186 21:07, 5 October 2006 (UTC)

...the source which claims chlamydia infections decreased in 2006 is a popular source about a paragraph long, which says "experts say..." and doesn't quote any experts. I think that fails WP:RS by itself. But, additionally, here is a September, 2006 citation from the WHO regarding chlamydia in Sweden which does not say infections have decreased: Cindery 09:46, 4 November 2006 (UTC)

Types of ECP -- Clarification

Under Types of ECP, Plan B, Levonelle, and NorLevo appear to be incorrectly labeled as combined ECPs containing both estrogen and progestin. From my knowledge (and by no means am I an expert) Plan B, Levonelle, and NorLevo are progestin-only ECPs. Can anyone confirm this error?—The preceding unsigned comment was added by Tonytnnt (talk • contribs) 10:07, 10 October 2006.

You are correct, Plan B, Levonelle and NorLevo are progestin-only ECPs. The reference to these progestin-only products was accidentally moved to the combined estrogen-progestin Yuzpe regimen paragraph in the Oct 1 Lyrl edit. I moved the reference to progestin-only products back to the progestin-only paragraph and restored information about recently discontinued dedicated Yuzpe regimen ECP products: Preven, Schering PC4, Tetragynon to the Yuzpe regimen paragraph.

68.77.148.27 15:27, 10 October 2006 (UTC)

Planned Parenthood's "financial interest"

I always find it kind of funny when people obsess over PP's "financial interests," like their counselors get a bonus if they sell so many abortions or something. People, Planned Parenthood is a non-profit institution. It certainly isn't getting rich off of the morning after pill. All Planned Parenthood chapters require donations and other forms of assistence to even cover their operating costs. I suppose that by getting pills at a discount from the manufacturer they're selling them at less of a loss, but I'm still willing to bet they aren't turning a profit off of them. --Jfruh (talk) 17:33, 20 October 2006 (UTC)

Rilly? I always find it kind of funny when people make ad hominem arguments (i.e., putting fact in does not equal "obsession.") As an aside, "Non-profit" org is pretty meaningless--there are plenty of ultrarich nonprofit orgs and NGOs (my faves are the corp shell companies like the Population Council--fat with Rockefeller oil cash.) "Requiring" donations is not proof of financial need. The IRS "requires your donations," too. Planned Parenthood is not a moral-value, it's just an org. (For which, like all hulking corporate entities, money is power--including power to make political endorsements.) Misplaced Pages WP:NOT place for my 100 page screed on why PP is Mcdonald's of women's healthcare--suffice to say I'd rather see more actual community-run women's clinics than PPs for the same reason I don't shop at Walmart. Cindery 18:45, 2 November 2006 (UTC)

OK, cooling off and ignoring issues of ideological purity as requested and merely tackling the logic here of the importance of PP's "finacial interest" -- surely making Plan B over the counter will reduce sales of the drug at Planned Parenthood? I mean, if you can walk into any CVS or Rite Aid and get Plan B, why would you need to find a Planned Parenthood location, since they're nowhere near as thick on the ground? The great advantage (to the patient) of going to Planned Parenthood for Plan B is that there is generally a doctor/nurse practitioner on staff there who can write a scrip and someone who can dispense it -- one stop shop. Make it over the counter and you largely remove the incentive to go there for your EC needs, unless you happen to live next door to one or something. --Jfruh (talk) 21:26, 2 November 2006 (UTC)

Well, except that they're cheaper on the sliding scale at PP for many people with low-income--and the more low income people who get their ECP at PP, the more subsidies PP can get for serving low-income pops. (And since they have privacy ethics at PP for teens they've got a kinda cornered market on that--pretty sweet, when it also comes with a discount...) But, the point about including PP financial conflict of interest is that, like all conflicts of interest, it doesn't prove anything/draw any conclusions--it's only information people can take into account. The conflict of interest doesn't have to mean anything, and it will undoubtedly mean different things to different people. COIs are disclosed so people can take them into consideration when evaluating what a source says...but, if PP has an exclusive deal with Barr and it means nothing, why didn't they disclose it? I haven't even seen a rebuttal to the criticism they received for having that deal and not disclosing it viz their endorsements. Perhaps I just didn't see it, and you can include their rebuttal to balance the article? I think that would be good/I will go look too... Cindery 05:03, 3 November 2006 (UTC)

--also: the suggested retail drugstore price is going to be around $40.00 (!)for one two-pill dose. a low-income discount is going to matter to a lot of people, esp. the youngest people, i think...that's a week's groceries for a college student... Cindery 05:07, 3 November 2006 (UTC)

Availability in the U.S.

I've added a little to the section on the tumultuous history of OTC Plan B in the U.S, specifically the sworn testimony of a couple of FDA officials that the drug was held up on political, rather than scientific, grounds in the FDA. MastCell 19:21, 20 October 2006 (UTC)

"social impact"

pls forgive me if i've missed where justification for renaming "related studies..." as social impact was given, and am not responding directly to the argument made. but, the huge prob with that is that the implication that ECP could have the social impact of reducing unintended pregnancies (the implication given by stating the number of unintended pregnancies, as if that had anything to do with ECP at all) is that it's conjectural. there has been no proven "social impact" --the actual data shows the opposite. since relating the US unintended preg stats with ECPS is utterly conjectural, i actually don't think the unintended preg stats should be in article at all--but i suppose a minor argument could be made that it's a minorly relevant tertiary stat. but certainly not a "social impact." Cindery 18:30, 2 November 2006 (UTC)

My idea for the section was as a place to discuss the hopes of ECPs impact on society, and the actual studies. There was information there on the high expectations of ECPs - all the feel-good stuff about raped women not getting pregnant - and also information on studies of the actual non-effect of ECPs on societal abortion rates.

I strongly object to including information on abortion rates in the "Effectiveness" section - that is completely unrelated to the ability of the pills to lower the risk of pregnancy in women who use them correctly. I also feel that giving all the feel-good statistics their own section overly emphasizes them, when in actuality the hopes represented by the publishing of such statistics have remained unfulfilled. Lyrl _Contribs 00:33, 3 November 2006 (UTC)

I agree that abortion rates should not be under "effectiveness" for the same reasons Lyrl mentioned. It would be more appropriate under "social impact", "other studies", whatever you want to call it. MastCell 01:08, 3 November 2006 (UTC)

...i'm in the middle of doing my nerd-tastic exhaustive research thing :)--gimme a couple days, probably till mon or tues. i'm trying to find reliable sources that define "perfect use" viz EC--so far, it does appear to be defined as "use for a single act of intercourse" with "typical use" defined as multiple acts, but not to my satisfaction yet--i.e., one recent french study, some websites...i did find guttmacher article which makes very compelling case that the point of ECPs is to reduce abortion rates. And another very credible american pediatrics assn. article which trumpets ECPs solely for their "potential" to reduce abortion rates. I hope other people will pitch in and do some additonal research too. i haven't read over complete texts of FDA approval hoo-ha: that usually includes justification for why the drug is needed/useful, and could likely say "will reduce/has potential to reduce unwanted preg rates as backup for contraception" i have the feeling that since the text of the product insert was so severely limited viz efficacy claims AND there is the caveat "must not be used as reg contraception" that data regarding efficacy past "perfect use " defined as single-act-of-intercourse--indicated not-effective -over -time. (the perfect use scenario is hypothetical enough that readers of Wiki deserve some clarity on that.)

here is Mitchell D. Crenin MD, in Human Reproduction: "The apparent effectiveness of emergency contraception can be attributed both to the action of the treatment regimen and to the limited time during the menstrual cycle when pregnancy is possible. Because menstrual regularity can never be guaranteed (and therefore neither can ovulation) the contribution of ECPs in preventing pregnancy can only be estimated. Only a prospective, randomized placebo-controlled trial would allow an accurate measure; however, such a trial would be unethical. But it is obvious that some women would not have become pregnant without treatment." (He also makes some notes re studies excluded women with irregular cycles/only included the extremely regular-cycled...) i think the Wiki EC article now is unclear enough to be seriously confusing/misleading about what the efficacy stats mean--it should be clear that they are estimated/hypothetical (and that no treatment/likelihood of not getting pregnant anyway is something to consider is cost/benefit analysis. i think i may want to return to my earlier suggestion of clearly bulleted pro-cons, as there are in some of the BC articles, if not most-- "confusing to know when or if to take." "risk of using drug unnecessarily" vs. "high efficacy in clinical trials for single use and single act of intercourse.")

but to address your point directly re abortion stats and where they should go, while putting the abortion stats in at end of efficacy does imply that that has something to do with efficacy-- it doesn't explicitly say, for example, "the ultimate measure of ECP efficacy is that it doesn't lower abortion rates in countries where it has been available long term." it just cites the studies. perhaps after a few days of research, we can agree to make a separate section, following/related to efficacy, which includes the related studies n stats quote re unintended preg rates, the "hopes" that it will reduce abortion rates from the source i have to cite, and the china/europe data. Cindery 01:34, 3 November 2006 (UTC)

meaning: i think the potential compromise which does the greatest serice to readers is probably to write a little section about EC/abortion rates--hopes from sources that they will lower them in US/cites from sources that they haven't in other countries, and that that section should follow "efficacy section"--not be confusingly buried in a jumble of disorganized factoids at the bottom of the article... Cindery 02:04, 3 November 2006 (UTC)

I agree that it's important to include a section on abortion rates - the hopes that EC would reduce them, and the fact that such a reduction has yet to be documented by anyone. But I think if we imply in the article that "EC doesn't lower aggregate abortion rates, so it's ineffective and useless", we're doing a disservice to any individual who would look at this page and decide not to use it (I know, WP isn't medical advice, but still, what's written here has an influence). An individual's decision should be based on efficacy in an individual, not on whether EC reduces abortion rates nationwide. That's what I'm getting at when I think we need a clear distinction in the article between "efficacy" (in an individual) and "societal impact" (e.g. failure to lower abortion rates). MastCell 18:12, 3 November 2006 (UTC)

I think we're a millimeter away from total agreement--the only place where I would disagree with you is that An individual's decision should be based on efficacy in an individual, not on whether EC reduces abortion rates nationwide.--an individual's decision should be based on whatever the individual decides is important, given all the facts/it's not for us to decide which facts should influence their decision. (As per lung scan example, given the same info, different people will make different decisions.) We give facts/sources--they make the decisions. As long as the abortion rate section closely follows efficacy, I don't object to the "different section" thing. (There are still be some issue re the efficacy section itself, though--Crenin should be cited to make points clear that any efficacy claims are estimated, and that "it's obvious some women would not have become pregnant without treatment." Still working on researching accepted/standard def, if "perfect use is one act of intercourse"/"typical use is multiple acts of intercourse"... Cindery 19:49, 3 November 2006 (UTC)

I believe perfect use is 1)beginning treatment within 72 hours of unprotected intercourse, and 2)taking the pills according to package directions (together, 12 hours apart, whatever they're recommending now).

ECPs are believed to work through acting on the egg (preventing ovulation) or by interfering with the implantation process of the embryo. So why would it matter how many sperm are in the female's reproductive tract? If she doesn't ovulate, she's not going to get pregnant, no matter how many times she had intercourse. And if her uterus is made hostile to implantation, it doesn't matter how likely the creation of an embryo was, again, she's not going to get pregnant. I do not see the relevance of "single act of unprotected intercourse" to the effectiveness rate of ECPs.

Second, remember the intercouse being discussed here is unprotected intercourse. Someone who has many acts of intercourse using a barrier method, and then has a condom break - can use ECPs after that one act of unprotected intercourse, and still expect the perfect effectiveness rates - despite having had intercourse many times.

I'm not really sure the idea of "typical use" applies to ECPs at all. The population for typical use of other forms of birth control is the group of people who intend that method to be their only way to prevent pregnancy. It includes both people who are rigorous about using the method, as well as people who sometimes - over the course of a year - do not use the method at all.

• No group of people (that I am aware of) intend ECPs to be their only method of birth control.
• Including people who do not use ECPs in the failure statistics is, I hope obviously, problematic.
• Effectiveness rates for ECPs are for a single use, versus over the course of a year for most other pregnancy prevention methods.

Lyrl _Contribs 03:41, 4 November 2006 (UTC)

I think it's the lead paragraph that is problemmatic, and extremely confusing for general reader:

Effectiveness of ECPs

The effectiveness of emergency contraception is calculated differently than that of ongoing birth control methods. For ongoing methods, the effectiveness rate is defined as the number of pregnancies over one year of use. For EC, the effectiveness rate is defined in clinical trial conditions as the reduction in pregnancy rate from a single use of emergency contraception.

Calculating the exact effectiveness of emergency contraceptive pills is difficult because the risk of pregnancy is not a steady percentage--it is extremely high in the several days immediately before ovulation, and negligible the rest of the time. Different measures have been used to estimate the effectiveness of different types of ECPs. These measures include comparing two types of ECPs against each other, or assuming some average expected pregnancy rate such as 8% per act of intercourse.

Specifically:

• Lead is phrased to osbcure that the efficacy is only estimated, (since no placebo trial can be done for ethical reasons). You do say efficacy is estimated by comparing two types of ECP against each other, or assuming some average expected pregnancy rate"--but I think that's just a confusing way of avoiding coming right out and saying "Efficacy can only be estimated." The fact that "reduction in pregnancy rate" refers to "conception probabilities" calculated hypothetically should be made very clear to lay readers. Perhaps a clearer way to say it is only a slight modification: "Because trials which gave a true measure of EC efficacy would be unethical, EC efficacy can only be estimated. Different measures have been used..."

• It's also phrased so that Crenin's obvious point--since EC is prescribed ("used as directed" in fact means)--after unprotected sex regardless of fertility/fertility awareness--the efficacy rate is partly attributable to nonfertility. (My earlier point about the chance of not getting pregnant anyway, with Plan B being 75% effective, and doing nothing being 75% effective, too :-) However it is made clear, it should be made clear in plain language that the efficacy rate is partly attributable to chance/nonfertility/there is risk of superfluous use. Perhaps Crenin should be directly quoted "it is obvious that some of them would not have become pregnant without treatment."

Also, do you have a citation/citations for the comparison you make re BC and EC and calculating efficacy? This quote specifically: "The effectiveness of emergency contraception is calculated differently than that of ongoing birth control methods. For ongoing methods, the effectiveness rate is defined as the number of pregnancies over one year of use. For EC, the effectiveness rate is defined in clinical trial conditions as the reduction in pregnancy rate from a single use of emergency contraception." Have you merely inferred that the only way to calculate efficacy for EC is single use, and that this way is in contrast to how BC efficacy is calculated, or are there official sources that say that is the official designated efficacy calculation definition? Perhaps, if sources have not made the comparison/given this definition, it is better not to explain-by-comparison, but to note the trial conditions under which the efficacy rates were estimated in addition to saying "the effectiveness rate is calculated in clinical trial conditions." Cindery 04:34, 4 November 2006 (UTC)

perhaps clearer way to make previous point: giving info about the clinical trial data (not every study, but the clinical trial data used to obtain FDA approval etc) clearly tells the reader what sort of information they are getting: clinical trial data. Making a comparison to BC and quoting statistics is very confusing--EC stats and BC stats aren't comparable, etc.--pill stats are based on 30+ years of postmarketing surveillance, not just "ongoing" use factor. There is the danger of implying that 57-80% effective means 50-80% effective in the way that the pill is 98% effective--it's confusing to readers to make that kind of comparison. I think a lot of confusion in the efficacy lead can be resolved just by removing the comparison to BC.

I believe the definitions I've been using of perfect/typical effectiveness are consistent with Pearl Index and decrement table and influential publications such as Contraceptive Technology. Lyrl _Contribs 21:01, 4 November 2006 (UTC)

Pearl etc are measures for BC, adding to confusion in lead paragraph re statistics and what they mean for EC I think--pls see suggestions under "lead efficacy paragraph" below. Cindery 21:24, 4 November 2006 (UTC)

I agree about the confusion, and did not intend my reply here to be promoting their inclusion in the article. I was only replying to the question about where I got the definitions of perfect/typical use. I had included discussion of ongoing BC effectiveness in the first iteration of the effectiveness section because I am very familiar with BC effectiveness, and comparison with that best helped me understand how ECPs effectiveness is calculated. However, after reading your proposed paragraph below, I now understand how much better that approach is for those (probably most people) not already familiar with effectiveness calculations of ongoing forms of BC. Lyrl _Contribs 23:24, 4 November 2006 (UTC)

Perfect use

I'm not really sure the idea of "typical use" applies to ECPs at all

Having done some research, I think you make a good point. Even if there were a consistent/standard/accepted definition of what perfect/typical could be for EC, it still wouldn't be the same kind of info as those stats for BC, since EC is not BC. "Perfect use/typical use" are BC terms. So...why are there perfect use/typical use slots in the infobox? We need a new infobox. (And that %11 stat needs to go--what is it referring to, anyway?) Cindery 05:40, 4 November 2006 (UTC)

If you post a request at Template talk:BirthControl infobox, I'm sure someone more up on template coding than I am would be happy to modify the template.

I believe the 11% stat is from a WHO study for women who began treatment within 24 hours of unprotected sex. I can't find a ref for it, though, and don't think it should be in the infobox anyway. I'm going to go change it now. Lyrl _Contribs 15:13, 4 November 2006 (UTC)

Refusal clauses

I think the wikilink to Conscience Clause (medical) was helpful and the PP citation doesn't make sense without some of the context that was removed in the last edit. Here is a news article from BMJ that covers this. If anyone is feeling up to it, I think we should try to work up this section a little more. If not, I'll see if I can't find the time to do it sometime this weekend.--Andrew c 03:20, 4 November 2006 (UTC)

As far as I know, CC wikilink was never in this article--but, it should be--I looked at the article, and it makes a better case than the PP cite. The PP cite was the only cite ever provided (and I fixed the broken link for it). The problem with the PP cite is that it never supported the assertion "there has been great controversy" over conscience clause viz ECP/it only describes two instances of pharmacist refusal re EC (and a couple re OCPs.) No objections to improved account-of-controversy, with better sources.

Cindery 03:32, 4 November 2006 (UTC)

...the BMJ article is kinda bland and barely mentions EC at all--but here's something juicy about Walmart, that rises to level of "big controversy," I think--is there more somewhere indicating that the nation's largest drugstore chain refused to carry EC? (Walmart says it is "business decision" has nothing to do with "conscience," though. Not that I believe that, but it makes it harder to include under pharmacist conscience clause section--does Walmart contradict itself somewhere else, maybe?) : Cindery 03:40, 4 November 2006 (UTC)

Efficacy lead paragraph

I think something like this helps explain what the statistics mean/should preface the studies/be in the lead paragraph. (it's mostly reworded from the "Effectiveness" sections of the two citations below--Medline and American Family Physician). But, I don't think it's perfect or anything/can be tweaked, and Crenin should be cited also. I just think sources should be used to explain how the efficacy is calculated, and what the 8% probability rate is and how it relates to EC and the stats derived--both of these sources use the "100 women had unprotected sex mid-cycle, 8 of them would become pregant" and cite EC as capable of reducing 8 to 2 to explain.

The effectiveness of emergency contraception is calculated hypothetically, and expressed as a percentage reduction in probable pregnancy rate for a single use of EC. Clinical placebo-controlled trials that could give a true measure of effectiveness for EC would be unethical, so the effectiveness percentage must be estimated. The estimates are calculated based on an 8% pregnancy rate mid-cycle after a single act of intercourse. For example, if 100 women had unprotected sex two weeks after their last menses, 8 of them would statistically become pregnant. If they all took EC, this number might be reduced to 2, depending on the method of EC. The reduction of the odds from 8 to 2 translates to 75% effective. But it does not mean that 25% of EC users become pregnant, or that 75% do not. The percentage reflects the reduction of the odds of pregnancy, based on probabilities, for a single use of EC.

I like almost all of it. I'm not thrilled by the word "hypothetical" in the first sentence - it implies the effectiveness is highly inaccurate. The consensus seems to be that, while not exact, 75% is a decent estimate.

I'm also not sure about the "8% probability of pregnancy on cycle day 14" statement. The fertility awareness article cites a study finding a pregnancy rate of 67% for a single act of intercourse, with timing based on cervical mucus. The focusing on cycle day 14 seems to 1)perpetuate the myth that all women ovulate on that day, and 2)downplay the risk of pregnancy from unprotected intercourse. I really like the example of reducing 8 to 2 - it's just the focus on CD14 that I am uncomfortable with. Lyrl _Contribs 20:58, 4 November 2006 (UTC)

What about "statistically" instead of "hypothetically"? I also agree about the 14 day wording. The AAFP link says It is important to communicate to patients that these numbers do not translate into a pregnancy rate of 25 percent. Rather, they mean that if 1,000 women have unprotected intercourse in the middle two weeks of their menstrual cycles, approximately 80 will become pregnant. Use of emergency contraceptive pills would reduce this number by 75 percent, to 20 women. I think there is a big difference between "middle two weeks" vs. "two weeks after". --Andrew c 22:07, 4 November 2006 (UTC)

oops, sorry, I didn't see that you replied here.

• re "hypothetical"--it cuts both ways, though, is totally neutral. meaning: helps reader understand that 75% doesn't necessarily mean 25% pregnancy rate. (but doesn't mean 75% not-pregnant rate, either--they are estimated probability calculations, not measures of events which have occurred, as stats would mean for BC trials--the point is, what do the stats mean? how are theoretical probability stats different from actual-measure stats?)

• the accuracy of the figure of 8% isn't what's being addressed, it's: which number/figure was used in the EC probability calculations, according to sources? (Additional info re pregnancy probability--other factors at play, regularly-cycled participants, myth of standard regular cycle at all, Crenin's point/your point that even regular cycles cannot be relied upon to stay regular---that could all be addressed, but I don't think it's helpful in the lead: there should be clear explanation of what the stats mean and how they were calculated, based on sources which address EC.

Cindery 21:35, 4 November 2006 (UTC)

Two of the five definitions of "hypothesis" - "asserted merely as a provisional conjecture to guide investigation" and "a mere assumption or guess" - are negative. Two others - "a proposition assumed as a premise in an argument" and "the antecedent of a conditional proposition" - are not relevant to the usage here. To me, the word in this usage has a more negative than positive connotation. I also do not see how it helps the reader understand that effectiveness rates are not directly related to pregnancy rates - in this construction, "hypothesis" applies to the calculation, not to the rate itself.

I support either changing to "statistically" per Andrew or changing the sentence to read "...effectiveness of emergency contraception is expressed as a percentage..." to get around the hypothesis issue. Lyrl _Contribs 00:30, 5 November 2006 (UTC)

I think I agree with you that "hypothetical" may be misread by lay readers--but "statistical" doesn't provide clarity in this context/as substitute for "hypothetical"--statistics are derived from different kinds of studies, which have different accepted values for evidentiary value for hypothesis testing...i.e., it's not just the statistic, it's the kind of study from which the statistic was derived. ...a "true" or accurate measure of EC effectiveness would be considered by standard medical statistical knowledge to come from a double blind randomized placebo controlled study. "Case-control" study etc more hypothetical in comparison. (Although in reality, both are hypothetical, the accepted medical value of "true" value is the placebo-controlled...) But I think you are right that "hypothetical" implies something else to lay readers than it means. Is there another good way to explain that the 25% doesn't necessarily mean 25% pregnancy rate? There's a serious risk of overusing the word "estimated," if synonyms can't be used, and it is not inaccurate to imply that there's a measure of speculation and conjecture in estimates, esp. estimates based on studies with no plabebo control group, in comparison to studies with placebo control groups--I think that's exactly what needs clarity: the element of conjecture in an estimate derived from a case-control study. Perhaps this can be very simply resolved jusy by saying "estimated statistically in a type of study considered less reliable than a placebo-controlled clinical trial" instead of "calculated hypothetically"?) Cindery 01:11, 5 November 2006 (UTC)

Possible synonyms for "estimated": "projected", "surmised", "extrapolated". I believe the rest of the paragraph excellently explains (aside from the issue about "two weeks after last menses") the process by which effectiveness rates are calculated. I don't believe including a qualifier in the first sentence is necessary, when the second and remaining sentences all explain the uncertainties involved in the calculation. Lyrl _Contribs 02:24, 5 November 2006 (UTC)

agreed re "two weeks after"--sorry i have neglected to note agreement.

re hypothetical: except...the way the efficacy is calculated for EC is hypothetical, even for a study with no control group. in mifepristone trials, for example, unethical to have control group of non-pregnant women, but everybody who took mifepristone in the study was pregnant. for EC, the "expected pregnancies" prevented are all hypothetical: 100 women take EC after unprotected sex. There is no way to be sure how many of them will become pregnant--this is instead estimated by 8% chance that they would become pregnant, but everyone agrees this percentage is conjectural, as even the regularly-cycled are not guaranteed to always have a regular cycle, among other variables. From the number of "expected pregnancies" estimated would result--8--the number of pregnancies which resulted after EC use is subtracted. The pregnancies prevented are all hypothetical; presumed to have been likely to occur (unlike mifepristone, in which there is no doubt as to whether pregnancies were terminated or not). I think you are right that a qualifier in the first senetence doesn't make this plain--maybe in the studies section, a brief description of study-design (which would be good place to explain the yuzpe comparison study design, why it was done, how it was an exception to the other studies, what the 50% stat means) could explain better...? Cindery 03:03, 5 November 2006 (UTC) Cindery 03:03, 5 November 2006 (UTC)

"Used as directed"

I think somewhere, perhaps in efficacy section but not lead paragraph, it needs to be explained simply for lay readers why there is an apparent discrepancy between the directions: "Use after unprotected intercourse. May be used at any time during menstrual cycle" and the actual fertility window/why no information is given in the directions to note/estimate/take cycle-point, cervical mucus, etc into consideration as factor for single-use decision. It's still not really clear to me if the 8% probability rate refers, as Lyrl concluded in our previous discussion about this, to a number factored out to 8% per day, regardless of cycle point, or if it refers only to a mid-cycle point probability number. I.e, how is the variability of fertility accounted for in the stats to arrive at a number which gives an efficacy rate for which no fertility calculation is required on the part of the user? Is it the 8%, or does the 8% refer only to mid-cycle, while the directions for use do not address mid-cycle, leaving a gap/discrepancy? (Assuming that Yuzpe/Plan B comparison study, which arrived at the "at least" 50% probability for Plan B after the controversy that Plan B's efficacy was overestimated in the previous studies doesn't refer to the "baseline" for fertility-factored-out-over-month to render user calculations unnecessary...) Simplest summary: if fertility is in effect for only three days, why do the directions say just take after unprotected intercourse, at any time of cycle? Do the efficacy stats reflect an average monthly rate? Cindery 22:06, 4 November 2006 (UTC)

Risk of pregnancy in the first six days of menstruation is less than 1% per-year according to Kipley. This only applies if the woman never (or at least in the past year) has cycles of less than 26 days, and only applies to bleeding following confirmed ovulation. Annovulatory bleeding is always potentially fertile. So that takes out the first week of the menstrual cycle, usually.

Risk of pregnancy from 3 days after confirmation of ovulation to the beginning of menstruation is also less than 1% per-year. Almost all women have between 10 and 16 days between confirmation of ovulation to beginning of menstruation, so that takes out the last week of the menstrual cycle. Actually, that takes out the last two weeks for some women.

Considering the above, and assuming every women has a 28-day (four week) cycle, I think I see where the "middle two weeks of the menstrual cycle" comes from. But 1)most women do not have 28 day cycles like clockwork. Any woman not practicing fertility awareness or some sort of hormone monitoring (urine test sticks or blood tests from a lab) 2)is not going to be able to differentiate true menstruation from annovulatory bleeding and 3)is not going to know when she ovulated. I think that middle two weeks bit is not relevant to the use of ECPs for the vast majority of the population. Though it's plausible that that 8% estimate in the calculation is only applying to those "two weeks" rather than the entire menstrual cycle. Lyrl _Contribs 23:40, 4 November 2006 (UTC)

I don't know if the preceding paragraphs sound critical, but if so it's not directed at any editors here. I'm just very frustrated at how completely ignorant most medical professionals (including researchers) are on the subject of female fertility. Lyrl _Contribs 23:41, 4 November 2006 (UTC)

I know that fertility awareness is your area of expertise, and I appreciate and respect your many useful contributions to Misplaced Pages with regard to that. But I think what should be clearly explained to the lay reader here is not how reliable is the 8% statistic, but-- what does it mean for EC use/the EC statistics per the sources and clinical trials? I think it would be great to link to/give some explanation regarding fertility awarness and FA calculations, after a simple, easy-to-understand explanation of the probability statistic used in the EC trials is given. (Westey et al refer to it as variable named "adjusted day of unprotected intercourse." Perhaps this is calculated around a mid-cycle percentage of 8%?) Cindery 23:51, 4 November 2006 (UTC)

Is it the 8%, or does the 8% refer only to mid-cycle, while the directions for use do not address mid-cycle, leaving a gap/discrepancy?.... if fertility is in effect for only three days, why do the directions say just take after unprotected intercourse, at any time of cycle? Do the efficacy stats reflect an average monthly rate?

I believe from the quote Andrew posted in the previous section that the 8% refers to only mid-cycle. I believe the directions say to take at any time of cycle because the reasoning behind restricting fertility to only mid-cycle is flawed. I agree that a more understandable explanation is needed for the article, but my talents do not seem to lie in crafting such explanations. Sorry about my long rant trying to answer this same question before. (Off-topic aside: women are fertile for 8-10 days each cycle, not just 3: 5-7 days before ovulation (sperm life), day of ovulation, two days after ovulation.)Lyrl _Contribs 00:22, 5 November 2006 (UTC)

No, your talents are very much in demand! I think maybe after just-name-the-conception- probabilities-as-given in clinical trials in lead, there should be a short paragraph explanation of fertility/fertility issues re EC to explicate readers' understanding of the terms-as-given (i.e., what is an "adjusted day of unprotected intercourse"? How does it pertain to EC use/what does it mean for EC effectiveness?--since we can't wikilink to the concept.) Meaning, first we just describe/give what terms/statistics were used. Then more light can be shed on them...? (After lead, before study summaries...?) Cindery 00:56, 5 November 2006 (UTC)

I believe the directions say to take at any time of cycle because the reasoning behind restricting fertility to only mid-cycle is flawed. I can't find this argument anywhere. Is there a source which can explain why the directions say to take at any time during cycle/effectiveness is not dependent upon fertility calculations by the user?

Cindery 15:42, 6 November 2006 (UTC)

"external validity" and variables

--that was me--sorry Wiki logged me out while editing. "Abortion rates and EC" section "under construction," not intended as complete (nor should it be 3.0, but subsection of 2?) Cindery 23:43, 4 November 2006 (UTC)

Current consensus re abortion rate section

Responding here to David, since "abortion rate" thread so long, and conversation about it continues into "social impact" section--

As far as I understand, the compromise reached was that abortion rates would have own section directly following efficacy, and discuss:

1. the standard arguments made in favor of/arguments for necessity of EC that it could reduce abortion rates (See, for example, here--Trussell's entire conclusion is that EC could/would lower abortion rates: Trussell J, Stewart F, Raymond E. Emergency Contraception: A Cost-Effective Approach to Preventing Unintended Pregnancy. A regularly updated review of the current literature, published online at Princeton University.)

2. the data from Europe and China on increased EC use/no decrease in abortion rates.

As far as a consumer use value/decision goes as a kind of rebuttal to the China/Europe data, I think it is fine to cite source (like one of the editorial letters to BMJ in repsonse to Glasier, or Glasier's quote itself which Mastcell quoted re individual use value/public health intervention value), but that after that is the place to note that "individual decicion" as opposed to "public health intervention" is not necessarily defined as "single use," and the opposite appears to be the case, as demonstrated by the increase of use from the OTC studies (and the China/Europe data.) Individual user decisions are not just for single use, but apply also to individual consumer use decisions to have an advance supply of EC on hand etc and use it multiple times. Nowhere is it specified by a source that "individual decisions" refer only to a single use or must be defined as a single use--single use is only specified as a variable used to calculate efficacy in the efficacy studies. (I think there's kind of a semantic argument going on in the pro-EC literature/current product insert to obscure that the annual failure rate is 20-24%, same as doing nothing. It makes sense that EC access would not result in fewer unwanted pregnancies--the failure rate is the same as doing nothing, and can only be obscured by claiming an efficacy rate for single use and implying it has no relationship to the annual failure rate. (Although Trussell notes that for Plan B, and only during ovulation, it is slightly better than doing nothing--but that by the same probability calculations, Yuzpe results in a higher failure rate than doing nothing. The likelihood that Yuzpe increases pregnancies, as Lyrl pointed out, is silly. But it doesn't refute the relationship, it shows that the numbers/pregnancies are hypothetical.) Meanwhile, even the "directions for use" do not say, must only be used once. They say, do not use as regular contraception. In between, is the place where studies have shown users use EC--multiple times per year, with the frequency being greater with greater access. Cindery 21:03, 5 November 2006 (UTC)

Annual pregnancy rate of using no form of birth control is 85%. That's over three times as high as 24%. Lyrl _Contribs 01:43, 6 November 2006 (UTC)

yes, you are right of course, per Trussell that it is 85%, (providing that one is healthy and one's partner is fertile) making annual EC rate more like withdrawl method rather than doing nothing.

But, the 85% is an average that varies by age (and fertility and age of partner), right? That would make EC a better efficacy risk for a 20 year old than a thirty year old? (Or, possibly worthwhile for a 20 year old and maybe not for a 30 year old.) And failure rate for Yuzpe is 35%, also per Trussell. (That causes some minor concern regarding the studies in which Plan B and Yuzpe were found to be equally effective.)

Regarding behavioral risk studies viz EC--I don't think they should go in abortion rates section. They should probably have a short section of their own, following abortion rates? Cindery 03:45, 6 November 2006 (UTC)

I agree behavioral risks should be separate from the abortion rates section. About the measures of efficacy, I think we're veering into an area where we're trying to rewrite the prescribing information. Let's focus on summarizing the available efficacy data with the appropriate sources. If we find criticism of the methodology of various studies amongst the many reliable sources out there, we can include that also. Right now the data indicate that EC is effective in preventing pregnancy in individual cases. However, greater access and use have not been shown to lower pregnancy rates nor abortion rates. Let's keep such things clear. We can include a quote from someone (say, Glasier) whom we can agree is untainted by the sulfurous smell of pharmaceutical company influence, to the effect that such a dichotomy exists and has implications for invidivual use vs public health use. Our opinions about the wording of the package insert, or the relative importance of "individual use" vs. "societal" arguments, are best kept out of the article, except insofar as we can quote reliable sources making such points. MastCell 06:24, 6 November 2006 (UTC)

I think you're making the mistake that Misplaced Pages is supposed to faithfully reproduce prescribing information or package inserts, when it supposed to be an encyclopedia entry, not medical advice/regurgitation of one source. that such a dichotomy exists and has implications for invidivual use vs public health use is opinion, and not exactly what Glasier said. I think the problem is that trying to make the case that the isolated single use efficacy stat="individual consumer use" is not accurate, and the implication that it does has a counterpoint.

With regards to the prescribing information, there are discrepancies between the prescribing information and accepted fact: 1. the annual failure rate is excluded from the prescribing information, but it is part of accepted fact, per consensus RS. 2. no information regarding user fertility calculations is given, but the importance of fertility calculations is essential for determing fertility, per consensus RS. Cindery 16:05, 6 November 2006 (UTC)

perhaps to add clarity: what Glasier/other people say is more like, "if you are desperate/have no other options, something is better than nothing." I'm inclined to believe and endorse both that some women, having no other options, and afraid they might be pregnant, will want to take EC and should have that option. I just think it should be clear that Glasier/source endorsement of the option--the possibility that EC could work-- is not necessarily a validation of the estimated 75% single use efficacy rate; and the 75% single use efficacy rate is not the justification given for why individual users might want to exercise the option. Cindery 16:17, 6 November 2006 (UTC)

No, I agree that we should go beyond repeating the prescribing information; that's why I think the sections on abortion rates, approval controversy, etc are appropriate. I just think that we're getting into territory where we're evaluating the studies/stats and glossing them based on our own views of their validity. This is a useful exercise for life in general, but for Misplaced Pages purposes I think we're in danger of straying from sourceable critiques and issues toward presenting our own interpretations of which statistics are most important, how the stats should be applied, etc. My point was just that perhaps we should go back to the sources a little more closely. MastCell 18:36, 6 November 2006 (UTC)

...the quote from Glasier is that EC is "better than nothing," not, say, "established consensus is that while EC is no longer believed to be useful as a public health intervention following these studies, it is highly recommended for individual users." And I think using that quote and not offering the explanation--which is included in the studies themselves--that lower efficacy/multiple use/no decrease in abortions are linked doesn't make sense...

"Anna Glasier, a family planning expert at the Lothian Primary Care NHS Trust in Edinburgh, UK, says that while the morning after pill is “better than nothing” for women who have had unprotected sex and do not want to get pregnant, it is not a useful public health measure for reducing abortion rates. In an editorial in the British Medical Journal today, Glasier writes: “If you are looking for an intervention that will reduce abortion rates, emergency contraception may not be the solution, and perhaps you should concentrate most on encouraging people to use contraception before or during sex.” Cindery 19:47, 6 November 2006 (UTC)

OTC section preserved for reference/new article start

Since December 2000, the official policy of the American Medical Association (AMA) has supported Food and Drug Administration (FDA) approval of over-the-counter (OTC) access to emergency contraception without a prescription in the U.S. The AMA, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and other leading U.S. medical organizations have passed resolutions and petitioned the FDA to allow OTC access.

On December 16, 2003, an advisory committee to the FDA recommended that Plan B be made available over the counter. The committee voted 23 to 4 to recommend Plan B be switched from prescription to OTC status. The committee unanimously voted 28 to 0 that the data demonstrated Plan B was safe for use in an OTC setting, and unanimously voted 28 to 0 that there was no evidence that OTC availability of Plan B leads to substitution of emergency contraception for regular use of other contraceptive methods.

However, in May 2004 the FDA refused this strong recommendation and prohibited over-the-counter sale. The FDA claimed that this was due to limited experimental data on the effects of such pills on girls under 16 years of age. Critics accused the FDA of basing the decision on political pressure. These accusations were supported by sworn testimony from FDA officials. Dr. John Jenkins, director of the FDA's Office of New Drugs, testified under oath that then-FDA Commissioner Mark McClellan had decided against approval even before the staff could complete their scientific analysis. In a separate deposition, Dr Florence Houn testified that she was told by Deputy Commissioner Janet Woodcock that Plan B needed to be rejected "to appease the administration's constituents", but that it could be approved later.

One year later, after the 2004 Presidential election, the makers of Plan B reapplied for over-the-counter status for women aged 16 and older. The January 2005 deadline for the FDA decision on this application passed without a decision. The FDA pledged to rule on the application by September 1, 2005, but the deadline was extended for at least 60 days. Barr re-filed its application for Plan B for OTC access for those 18 and older. President George W. Bush stated that he would support FDA head Andrew von Eschenbach's decision to approve Barr's application as long as minors did not get the drug without a prescription.. The FDA announced approval on August 24 2006 for emergency contraception sales to those over 18 years of age over-the-counter. Girls aged 17 and under still require a prescription. Plan B will not be available in gas stations or convenience stores as are some other OTC medications, and sales will be limited to locations with a pharmacist on staff. Before this decision, eight states (California, Washington, Alaska, Hawaii, New Mexico, Maine, New Hampshire and Massachusetts) passed laws permitting trained pharmacists to dispense emergency contraception without a doctor's prescription.

—The preceding unsigned comment was added by Cindery (talk • contribs) 13:20, 6 November 2006.

implanantation controversy redundancy preserved

this is all repeated in another section/I don't think it's inherently significant or neccessary to a definition of ECPs which prefaces an explanation of their types in more detail. (I am worried I have just screwed up all the references referred to in later section--will check and fix.)

Studies in rats and monkeys have shown that ECPs have no effect on pregnancy rates when taken after ovulation has already occured. When taken before ovulation occurs, ECPs prevent ovulation in 50%-80% of women, and this is the primary way in which they prevent pregnancy. If ovulation occurs despite pre-ovulatory use of EC, there may be changes in certain hormone levels such as progesterone and in the length of the woman's luteal phase. These changes are similar to those found in a woman's first few ovulatory breastfeeding cycles. Because these secondary effects might result in embryos being created, but prevented from implanting in the uterus, they have resulted in some controversy over the use of ECPs.

—The preceding unsigned comment was added by Cindery (talk • contribs) 16:51, 6 November 2006.

"No direct evidence"

"There is no evidence that direct access to ECPs without a prescription results in fewer unintended pregnancies than controlled access via prescription." Why not move this sentence to the section on efficacy or societal impact? It seems out of place in its current location (under "Legal/Ethical Controversies") as a summary of the political issues in the approval process. If the controversy is that the drug was approved in spite of an absence of efficacy data, that should probably get its own bullet point (i.e. separate from the political controversy) as well as a citation to someone raising that concern. MastCell 23:38, 7 November 2006 (UTC)

...I think it belongs there because it was one of the arguments made against OTC approval, in the actual controversy. The account of the controversy should probably reflect both sides of the argument/more of the con side, so that the cite I have included does not falsely appear to be the only against-argument. I have waded through some of the FDA dockets submitted pro/con, and there was a NEJM article giving both sides of the issue. The "other side" makes some compelling arguments against self-medicating--in the "actual use" study conducted at PP, 28% of women "didn't understand the directions" and some used EC even though it was contraindicated for them. (That same study has been claimed for both sides, with one side saying "most women self-administered correctly, therefore it should be available OTC" and the other saying "28% did not, therefore it shouldn't be available OTC") Also point about ectopic pregnancy, and danger of women not under medical supervision not noticing or seeking help or able to self-diagnose ectopic/danger of not self-diagnosing or seeking help in time, when time is critical. (More on ectopic from the product insert and the updated physician's warning re Levonelle shoudd be in article elswhere...)Anyway, I think at least a few points made by the anti-OTC side should be included for balance. Aside from any opinions you or I may have of the merits of the arguments on the opposing side in real-world debate, it should be a report of the actual real world debate, right? The opposing arguments are largely made by pro-lifers/the sources to cite are pro-life. But, pro-lifers are a huge "POV with adherents," and the OTC debate did have more than one side to it. For a neutral account, their POV should be included/they should be cited as sources-- even by us pro-choicers. Cindery 00:56, 8 November 2006 (UTC)

Sure... If you have some of the relevant cites, go for it. Otherwise I'll get around to digging through my old NEJM's. It might make sense to split the political controversy and the medical issues into 2 separate bullet points. MastCell 06:12, 8 November 2006 (UTC)

Perhaps simple solution is to say, right after --"FDA advisory committee..." --"Arguments submitted to the FDA against were blahblahblah. Arguments in favor were blahblahblah." (Main arguments TBD.) Then maybe Susan Woods' resignation over "abortion politics" could be mentioned--that clarifies what the big deal was about--and then the news story re the Raine study--both extremely briefly. They were both big-news events which occurred after initial pro-con arguments were made, actually. This would remove Raine study from appearing to be the "conclusion."

Not a directly related point, and minor, but: I think there should be a slight tweak to the reason given by the FDA--"experimental data" could be confusing for a reader who is not highly familiar with the subject--could it say something more like "insufficient evidence to conclude that EC could be used safely by adolescents without medical supervision"? (I think that is the actual FDA quote...) I think also "ostensibly" is overly leading/not encyclopedic style/not necessary--you cast enough doubt on the truthfulness of FDA's claims with sworn testimony, etc. "FDA stated" or "The stated reason given by the FDA" is probably better? First give their stated reason, then raise doubts/cast valid aspersions on it. (point-counterpoint instead of counterpoint-counterpoint. set 'em up and knock 'em down. Can't really knock 'em down if you don't set 'em up first, right? :-) I think "ostensibly" takes the drama out of the refutation provided by sworn testimony...(plus it's not really neutral to interpret the validity of their statement while giving it, rather than quote them.)

Also: I think "risky sex" shouldn't be jumbled into "related studies and statistics"--it should have its own little section that goes something like "Data on the relationship between increased sexual risk taking behavior and EC access either by prescription or OTC is inconsistent and inconclsuive. Some studies show a correlation, some do not. In Sweden and the UK, blahblah. In the US, the issue has been hotly debated viz OTC access for teens (insert idiotic orgy hype made up by Woodcock here), but a US study has shown that teens are not any more likely to engage in risky sex with OTC access than older people are." (Hence the studies will be organized so they make more sense to the reader, and it is another place where an aspect of the US controversy can be explained/put into context.) Cindery 22:49, 8 November 2006 (UTC)

Plan B and race in prescribing info

"No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in the Chinese population with both Plan B and the Yuzpe regimen (another form of emergency contraception consisting of two doses of ethinyl estradiol 0.1 mg + levonorgestrel 0.5 mg). The reason for this apparent increase in the pregnancy rate of emergency contraceptives in Chinese women is unknown."

I'm confused--is this/the reason for stating this in the prescribing info explained more anywhere else? A search of Cochrane database only reports that most of the efficacy trials took place in China, not a difference between progestin pharmokinetics in Asian/Chinese women and other women. (Most recent research on DMPA pharmokinetics and Asian women is that there is no difference between Asian/Caucasian...) But, I am not a progestin-pharmokinetics-by-race expert... Cindery 01:57, 9 November 2006 (UTC)

Preven prescribing info

This is the pdf: --I don't know how to format it as ref, but it should probably go after "Until 1998, the Yuzpe regimen was believed to prevent at least 75% of expected pregnancies." Cindery 02:28, 9 November 2006 (UTC)

Markup is along lines of:

<ref name="Preven">{{cite web | author=Gynetics Inc | title=Preven Emergency Contraceptive Kit | url=http://www.fda.gov/cder/foi/label/1998/20946lbl.pdf | format=PDF| work=Product labels | date=9 Jan 1998 | publisher= FDA | accessdate=2006-11-09}}</ref>

Gynetics Inc (9 Jan 1998). "Preven Emergency Contraceptive Kit" (PDF). Product labels. FDA. Retrieved 2006-11-09.

:-) Yours David Ruben 15:15, 9 November 2006 (UTC)

I don't think Yuzpe was ever widely believed to prevent 75% of expected pregnancies. When I was doing the PubMed searches to write the history section, there were lots of articles about "New pill could cut unintended pregnancies by half" and such - implying a 50% effectiveness, not 75%. Lyrl _Contribs 23:35, 9 November 2006 (UTC)

the history of yuzpe effectiveness and "belief" goes like this:

• first efficacy rate, asserted by yuzpe himself, was 100%
• this was slightly adjusted to 95-100%, based on the 100 women=100 pregnanices "theory" of fertlitiy...
• the silvestre meta-analysis was published in 1991, showing failure rate of 44-100%, causing big controversy about how the previous 95-100% efficacy was calculated
• trussell subsequently accounted for the 8% and published rate of 75% (see ref 18)
• fda approved preven based on 75% efficacy (see ref 11--I haven't looked at PC4 prescribing info, etc)
• subsequent studies reported efficacy to be more like 57%, yuzpe dedicated products pulled from world markets, etc.

Cindery 23:55, 9 November 2006 (UTC)

differences among studies in abortion rates section

...epidemiological comparisons between EC use + abortion rate different from randomized controlled trial of individual users. Cindery 03:17, 10 November 2006 (UTC)

Sure, but they both support the point Glasier was making. In general, it's most useful to have primary study data first, then an expert/editorialist summarizing "what it means". This improves readability for the general reader. MastCell 19:52, 10 November 2006 (UTC)

...No, I don't think the different kinds of studies are clear to the general reader unless they are separated. Randomized controlled trial should go last because it is medically accepted standard of greater evidentiary value/and it offers explanation of why the abortion rates are not lower. (this explanation is given by Glasier, who states that the studies may show not just that abortion rates aren't lower, but that they may not be lower because EC efficacy may be a lot lower etc, as efficacy is "based on a lot of assumptions that are impossible to validate.")

Wash times

This section references many nonsci sources, and rightfully so--it's not strictly about the medical aspects of EC. "Pop sources should be avoided" not "never used"--the important thing is to evaluate them/when and where they used. In this case, the source situates/contextualizes the significance of the study socially-what did people say about it? at what time did it occur in the history of events being discussed? what did the study researchers say about it? It's an extremely useful source for the reader in this context. Cindery 20:09, 10 November 2006 (UTC)

The text writes "A study showed...", then a link to the study. Fine. Then there's also a link to the Wsh Times. There's nothing in the text about interpretations of the study (and the WA Times is hardly a non-partisan source). It's fine to include WA Times as a source, but it needs to be clear we're citing the WA Times, and not the study in question. The text doesn't make that clear, and the WA Times article added little to what was already there. Ideally, regardless of what's done elsewhere, we should "avoid citing the popular press" per WP:RS; since the WA Times article doesn't add to what's stated in the article text, it's a perfect time to avoid citing it. MastCell 20:20, 10 November 2006 (UTC)

There's nothing in the text about interpretations of the study--there doesn't need to be--what the text says is "In 2005...", indicating that the year has some significance, and the study is included at a specific point in a narrative context. The Wash Times evenhandedly quotes both sides, and Raine (including giveing Raine the last word). This whole section gives newspaper sources--it's about the social/political context of a medical issue. Cindery 20:35, 10 November 2006 (UTC)

I'm not arguing that the Wa Times article is misleading; I'm saying that it adds nothing in terms of verifiability to the sentence in question, and pushes the limits of WP:RS. If we approach this article with the goal of getting it to featured-article quality (which I think is a worthy goal for any article one works on), then the sources need to be tightened up to accord with WP:RS; that will be one of the first issues in the process. I have no problem citing newspapers on sociopolitical issues, or if there's no alternative when describing a study. However, if the sentence is a straight description of a study, and we've already referenced the study in question, then a popular-press source is both superfluous and discouraged by WP policy. MastCell 22:16, 10 November 2006 (UTC)

I don't think you really grasp WP:RS--most of the sources cited in the "US legal controversies section" are news sources.

The edit summary for the addition of Wash Times article was link-study-to-controversy: the one sentence and the placement in context both have a source, in other words. Wash Times explains how the study pertains to the controversy/is a source indicating placement-in-context. Not every reader will understand from reading the study that it had something to do with the controversy/occurred at a specific point in the controversy. (That article is an extremely informative/useful source, and was cited by NARAL...) Cindery 22:31, 10 November 2006 (UTC)

Yes, but the other news sources are used for current events. The sentence in question is the only one in which a news source is quoted as the citation for a medical study. Leaving aside my comprehension of WP:RS, and some significant issues on this page with WP:OWN, the problem is simple: the paragraph discusses the political controversy (i.e. the role of a pro-life constituency on the approval process, testimony that the decision to reject was made before the scientific analysis was even performed). The sentence in question, about the Raine study, is out of place. There could well be another paragraph about scientific controversy related to OTC approval, where said study would fit right in. I agree readers won't understand why the study is mentioned there; we should either improve the prose of the article to make that clearer, or (my preference) move it to a new section (on scientific controversy over OTC status) where it would be more at home. MastCell 01:22, 11 November 2006 (UTC)

Yes, but the other news sources are used for current events--no, all of the news sources are cited for "recent" events, beginning in 2003 and extending to 2006, including the 2005 news source re the Raine study. It's a simple concept: the medical study was a medical study and a news story. Hence two citations. The two political sides are quoted/addressed in the news story, locating the study in the political controversy. Cindery 01:40, 11 November 2006 (UTC)

What's lacking is any indication, in the article paragraph, of how the study in question bears on the political approval controversy. MastCell 01:44, 11 November 2006 (UTC)

barret and marshall

...that's where i remember the 24% from: 24% is the per-month/per-cycle pregnancy rate for random acts of intercourse, per Barret and Marshall in 1969. (Still, as Lyrl pointed out, the comparison between EC use once with unknown number of acts of intercourse is difficult comparison to make to intercourse-all-month with unknown number of acts. But, if you have random unprotected sex all month, there's a 24% risk of pregnancy. If you have random unprotected sex all month and used EC after every time, the risk would be greater than 24%. If you had unprotected sex all month and only used EC once at midcycle, the risk is 25%.

The user directions/fertility calculations still need to be included /addressed somewhere, I'm just not sure where. I did find American Assn of Pediatricians article which gives what I am guessing is the argument Lyrl was referring to--it says, more or less, midcycle fertility should be calculated into decision to take EC, but if date of LMP is unknown --and because date of ovulation can vary from person to person and cycle to cycle--there can be a risk of pregnancy any day. (But there's a big diff between "take after unprotected intercourse" and that...) Cindery 20:38, 10 November 2006 (UTC)

too much information

"Dr. John Jenkins, head of the FDA's Office of New Drugs, testified under oath than FDA Commissioner Mark McClellan had decided to reject the OTC application before the scientific analysis had been completed."

• we already have one example that makes the point that the center for reproductive rights/pro-choice side believes the FDA was influenced; one is enough

• there's mcclellan's rebuttal, which would make this way too long, but must be included (and inclusion would weaken/drown in wordiness a clear point about woodcock)--mclellan's rebuttal is a) that he did consider the scientific evidence b) that he left before the decision was made.

• this clutters the paragraph with names that aren't familiar to a lot of people, and it isn't a cross section of the most important names that could be mentioned (makes no sense to mention mclellan but not galson or eschenbach...)

• all depositions are sworn under oath--that's what a depostion is, and there's a wikilink to depostition already.

Cindery 01:57, 11 November 2006 (UTC)

1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?orig_db=PubMed&db=PubMed&cmd=Search&term=%22Lancet%22%5BJour%5D+AND+365%5Bvolume%5D+AND+1668%5Bpage%5D)
2. "Interim Meeting (Access to Emergency Contraception)". ama-assn.org: December 2000. Accessed August 2, 2006.
3. "Briefing Document (1.2.4 Plan B: Rx-to-OTC Switch)". FDA.gov: December 16, 2003. Accessed August 2, 2006.
4. "Panel backs over-the-counter 'morning-after' pill". CNN.com: December 17, 2003. Accessed April 28, 2006.
5. "FDA Advisory Committee meeting documents". FDA.gov: December 16, 2003. Accessed August 2, 2006.
6. Kaufman, Marc. "Plan B Won't Be Sold Over Counter". Washington Post. May 7, 2004; Page A01. Accessed April 28, 2006.
7. ^ Reuters article on political aspects of Plan B approval. Accessed 20 Oct 2006.
8. Bush supports limits on morning-after pill
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